Career

Zenith LifeScience LLC is a fast-growing premier contract research organization providing end-to-end clinical development services to Life Sciences and Healthcare industry. We are expert in providing comprehensive, integrated Clinical Research Support and life cycle management services. Currently Looking to fill following job openings.

CLINICAL TRIAL ASSOCIATE

Department: Quality & Regulatory Compliance (Clinical Operations)

Zenith Lifescience, LLC has job openings for Clinical Trial Associate. Job is located in South Plainfield, NJ and various unanticipated locations throughout the U.S.

Responsibilities:

• Coordinate and document internal regulatory processes for pharmaceutical clinical studies.
• Prepare site regulatory documents, eCRFs, paper CRFs, and Clinical Trial Agreements
• Support clinical trial supply and infectious disease sample shipments while adhering to regulatory standards.
• Evaluate suppliers, analyze price proposals, and maintain records of purchased items, costs, and inventories.
• Draft protocol and ICF documents, submit to IRB/EC, and respond to queries.
• Coordinate with data management team to clean and transform raw data for analysis.
• Maintain and update clinical study documents using eTMF.

Educational and/or experience requirements:

• Master’s degree or equivalent in Healthcare Informatics, Pharmacy, Healthcare Administration or related field with at least two (2) years of experience in job offered or related occupation such as Procurement Specialist or Clinical Study Administrator.
• Any suitable combination of education, training, or experience is acceptable.
• Travel/relocation may be required.

Job Type: Full-Time

Offered salary: $110,490.00 / Year

Mail resume with proof of work eligibility to: HR, Zenith Lifescience LLC, 51 Cragwood Rd., Suite 306, South Plainfield, NJ 07080.

– Posted on 08/15/2023

DRUG SAFETY ASSOCIATE

Department: Quality & Regulatory Compliance (Clinical Operations)

Zenith Lifescience, LLC has job openings for Drug Safety Associate. Job is located in South Plainfield, NJ and various unanticipated locations throughout the U.S.

Responsibilities:

• Coordinate and document internal regulatory processes for pharmaceutical clinical studies.
• Receive, evaluate and report Serious Adverse Event (SAE) reports from clinical trials.
• Submit SAE reports to regulatory agencies.
• Perform quality review of Adverse Event data entry, MedDRA, WHO-Dictionary coding, Narratives and labeling of cases.
• Assist validation department by authoring and executing scripts for safety database upgrades.

Educational and/or experience requirements:

• Master’s degree or equivalent in Pharmacy, Chemistry or related field with at least two (2) years of experience in job offered or related occupation such as Business Analyst or Drug Safety Specialist.
• Any suitable combination of education, training, or experience is acceptable.
• Travel/relocation may be required

Job Type: Full-Time

Offered salary: $93,392.00 / Year

Mail resume with proof of work eligibility to: HR, Zenith Lifescience LLC, 51 Cragwood Rd., Suite 306, South Plainfield, NJ 07080.

– Posted on 08/15/2023

CLINICAL DATA ANALYST

Department: Clinical Research & Data Management

The Clinical Data Analyst plays an essential role in the data collection & Data evaluation phase of clinical research. The process of collecting, managing and analyzing research data is done in accordance with regulatory standards to obtain quality information that is complete and error-free; the goal is to gather as much of such data for analysis as possible. The inherent goal of any clinical data manager is to produce, analyze and maintain quality data.

Responsibilities:

• Performing and Project managing clinical Data Management (DM) activities for clinical trials including protocol review, CRF (Case Report Form) development, database set up activities, data validation process (including manual data review of listings), and SAE (Serious Adverse Events) reconciliation, managing local laboratory and external labs and database lock.
• Representing Data Management on clinical teams and coordinate deliverables by other functions and/or CRO (Clinical Research Organization) as necessary to achieve DM deliverables.
• Coordinating with Programming team to provide support to the data review and safety updates (coordinate generation of data review listings, data retrieval to support data review and analysis, SDTM (Study Data Tabulation Model).
• Responsible for all data cleaning activities for multiple Respiratory studies and a COVID-19 vaccine study by managing thousands of trial participants and ensuring data accuracy and completeness throughout each study.
• Responsible for Data cleaning using system programmed checks (System queries) and twice weekly SAS generated listings in Medidata Rave and Inform EDC.
• Coordinate CRO (Clinical Research Organization) data validation activities (coordinate data transfer specs, data reconciliation, query generation and resolution).
• Worked on a tool called EXACT/SAS for data cleaning of Core checks (DOV errors, basic checks for studies) EDU checks (Vendor related checks) & MRL checks (Study specific checks)

Educational and/or experience requirements:

• Bachelor’s or Master of Science in health informatics or Clinical Research
• Good Understanding and experience in clinical trials and regulatory documents
• Hands on experience on clinical data analysis activities

Job Type: Full-time

Salary: $80,000.00 to $100,000.00 /year

Please send profile at careers@zenithlifescience.com for direct consideration or question.

-Posted on 02/11/2023

Lead Validation Engineer

Department: Product Life cycle Management/Validation

Zenith Lifescience, LLC has job openings for Lead Validation Engineer. Job is located in South Plainfield, NJ and various unanticipated locations throughout the U.S. Analyze validation test data to determine whether systems or processes have met validation criteria and to identify root causes of problems for various pharma and other facilities.

Responsibilities:

• Prepare validation, installation and operational qualification and performance qualification protocols for new or modified processes, systems, or equipment for various production types.
• Coordinate the implementation or scheduling of validation testing with affected departments and personnel.
• Create, populate, and maintain databases for tracking validation activities, test results, and validate systems.
• Work with various technologies such as Minitab, Microsoft Visio, and 5 Whys Tools.

Educational and/or experience requirements:

• Travel/relocate to various unanticipated locations throughout the U.S. for long and short term assignments at client sites.
• Requires Bachelor’s degree or foreign equivalent in Biomedical Engineering, Regulatory Affairs, Chemistry, Biochemistry, Technology (any), Biology, or a related life sciences discipline and 5 years of experience in the job offered or as a Validation Engineer Professional.
• Will also accept Master’s Degree or foreign equivalent in Biomedical Engineering, Regulatory Affairs, Chemistry, Biochemistry, Technology (any), Biology, or a related life sciences discipline and 3 years of experience in the job offered or as a Validation Engineer Professional.

Job Type: Full-Time

Offered salary: $136,000.00 / Year

Mail resume with cover letter to Zenith Lifescience, LLC, 51 Cragwood Road, Suite 306, South Plainfield, NJ 07080; Job 20ZEN03; EOE

– Posted on 09/01/2022

Validation Engineer

Department: Product Life cycle Management/Validation

Responsibilities:

• Perform Commissioning, Qualification, Validation and Re-validation activities on Equipment, Utilities, and Facility used in the Pharmaceutical Drug Manufacturing and Quality Testing in FDA approved CGMP facilities.
• Draft and review Validation Life Cycle documentation for Equipment, Utilities and Facility such as Qualification protocols [Installation Qualification (IQ)/ Operational Qualification (OQ)/ Performance Qualifications (PQ)], Specification documents such as User Requirement Specifications (URS), Functional Requirement Specifications (FRS), Software Specifications (SS); Validation Summary reports, Deviations reports, Periodic Reviews. Author Traceability matrix and performing functional risk assessments for GMP critical requirements
• Author Traceability matrix and performing functional risk assessments for GMP critical requirements.
• Draft user requirement specifications (URS), summary reports, and traceability matrix for Cell Processing Equipment such as -20ºC Freezers, -75ºC Freezers, LN2 Freezers, Refrigerated Centrifuges, Tube Sealers, Tube Welders, Particle Counters, Nucleo-Counters, Spectrophotometer, Vi-CELL BLU, Controlled Rate Freezers, Thawing Device, Flow Cytometer, Cell Count & Viability Analyzer and Spinning Membrane Cell Washer
• Address & Draft deviations when the test results failed to meet the acceptance criteria during Installation and Operational Qualification and perform root cause investigation & impact assessment, implementing corrective actions, and documenting the justification for acceptance after implementing corrective actions.
• Perform Installation and Operational Qualification (IOQ) of Cell Processing Unit Equipment’s in Production, Warehouse/Storage Room, QC, and Bioassay.
• Participate in Aseptic Process Validation of manufacturing processes.
• Generate and execute Qualification (Installation, Operational and Performance) of Refrigerators, -20ºC Freezers, -75ºC Freezers, LN2 Freezers, Refrigerated Centrifuges, Tube Sealers, Tube Welders, Particle Counters, Nucleo-Counters, Spectrophotometer, Vi-CELL BLU, Controlled Rate Freezers, Thawing Device, Flow Cytometer, Cell Count & Viability Analyzer and Spinning Membrane Cell Washer.
• Perform 24 hours temperature mapping for Re-qualification of 2-8 ºC Refrigerators, -20ºC Freezers, -75ºC Freezers, LN2 Freezers, and CO2 Incubators using Kaye Validator (2000, AVS) (Thermocouples) and Kaye ValProbe data loggers.
• Perform Non-Viable Particle Assessment for various equipment’s in ISO7/Grade B areas such as Cell Washer and Cell Selector & Washer located in Grade B Area.
• Provide status updates on commissioning, Qualification and Validation activities for Project Management to discuss milestones and initiate brain stroming sessions on solving non-conformances that arise during validation activities.
• Perform Temperature Mapping of Controlled Temperature Units (CTU’s) utilizing Kaye Validator (2000, AVS) (Thermocouples) and Kaye ValProbe data loggers.
• Program data loggers and humidity loggers for qualification of CTU’s, Cell Production Suites, and Support Areas and Storage Room qualifications.
• Generate reports to Analyze validation test data to determine whether systems or processes have met validation criteria or to identify root causes of production problems by generating reports from Equipment or Room Monitoring System (EMS/RMS) and Building Monitoring System software such as trend data (min, max, and avg) and Graphs using Info Center Software application for various parameters such as temperature, humidity and CO2%
• Perform facility qualification, static and dynamic qualifications of manufacturing room and support areas.
• Assist in the qualification of Pass Thru’s, CO2 Incubators, Refrigerated Centrifuges, Storage Room IOQ, Static and Dynamic IOQ of Cell Production Suite and Support areas.
• Provide technical expertise to define approaches and with cGMP, cGXP, CFR 21 parts 11, 210 and 211, EU annex 11, ICH Q2, Q7, Q8, Q9 and other applicable regulations, procedures and pharmaceutical industry guidance.

Educational and/or experience requirements:

• A minimum degree of bachelor’s or higher degree in Pharmaceutical Engineering or closely related
• 3-4 years experience in Adverse Event reporting
• Hands on experience with performing Commissioning, Qualification, Validation and Re-validation activities on Equipment
• Good Understanding of Pharmaceutical Manufacturing & cGMP Regulations, Pharmaceutical Engineering (Unit Operations), Chemistry and laboratory

Job Type: Full-time

Salary: $70,000.00 to $80,000.00 /year

Please send profile at info@zenithlifescience.com for direct consideration or question.

-Posted on 08/31/2022

SR. DRUG SAFETY ASSOCIATE

Department: Quality & Regulatory Compliance (Clinical Operations)

Responsibilities:

• Executed receipt of Drug Safety phone calls and complete telephone AE form
• Created phone call communication logs into the database and triage of cases as needed.
• Implement and executed QC on key fields of serious cases
• Executed case assessment (review events, determine labeledness, identify co-manifestations, review coding, determine causality
• Created clear concise clinical case narratives, review and updated auto-narrative as needed.
• Created company pharmacovigilance comments for causality assessment, dechallenge/rechallenge determinations and performed event rankings.
• Perform case handling including receipt, book-in, assessment, duplicate-check, seriousness, expectedness, case processing, Narratives, Follow up’s, Quality check and Submissions.
• Review and process device cases, clinical trial cases, and potential litigation cases received from different sources.
• Perform accurate coding of Adverse Event and product for all incoming serious and non-serious cases using medical terminology via MedDRA (Medical Dictionary for Regulatory Activities) and WHO Drug Dictionary.
• Quality review of ICSR’s concentrating primarily on Narratives, Product coding, Medical coding for any possible discrepancies with the related source documents and sending reports related to the same to the concerned product managers and case processors.
• Electronic reporting (E2B) of all necessary reports, expedited safety reports, ensuring successful timely submission and collating acknowledgments of ICSRs from Regulatory Authorities and Business Partners.
• Determined follow-up needs for AE reports.
• Reviewed and updated generated follow-up letters as appropriate
• Leveraged professional background in pharmacovigilance to support Quality Assurance through reviewing documentation, client agreements, and regulatory guidelines.
• Maintained knowledge of company/client product safety profiles and manufacturing processes to respond to all medical and technical inquiries related to pharmacovigilance.

Educational and/or experience requirements:

• A minimum degree of bachelor’s or higher degree in pharmacy or closely related field
• 1-2 years experience in Adverse Event reporting
• Hands on experience with ARGUS or ARISg
• Good Understanding of MedDRA & WHO drug dictionary

Job Type: Full-time

Salary: $70,000.00 to $80,000.00 /year

Please send profile at info@zenithlifescience.com for direct consideration or question.

-Posted on 08/16/2022

CLINICAL DATA MANAGER

Department: Clinical Research & Data Management

The Clinical Data Manager will support the Data Management group from study start-up through database lock and clinical study report using EDS and Statistical tools. The successful candidate will deliver high quality data, on time and on budget. In this role, the candidate will be expected to lead and provide oversight for the execution of data management activities for more than one compound in a therapeutic area.

Responsibilities:

• Design and develop electronic Case Report Forms (eCRFs) for Inform database during study start-up activities.
• Conduct requirement workshops with key stakeholders to collect the opinion on what data can be collected and how it should be collected in the electronic case report form of the database
• Conduct surveys and receive the feedback from data management team & Clinical operations team on the report.
• Build and test the Case report forms based on the finalized study requirements.
• Run Reports in InForm/J-review for data interpretation and analysis to identify query and SDV (source data verification) metrics.
• Create tables, listings and graphs with the subject data to ensure the data conformance with study protocol and identify data quality issues & trends.
• Work with the data stewards and remediate the data quality issues.
• Performing user acceptance testing of the database using Inform.
• Review the User acceptance test scenarios and provide the feedback to testing team
• Perform User acceptance testing for the key scenarios.
• Perform predictive modeling so that outcome of the future trials can be predicted.
• Apply appropriate mathematical and statistical theories to determine the next steps based on current indications of the clinical trial.
• Provide the conclusions from the study to support to strategic collaboration executive decision making
• Resolving data issues from clinical, SDTM, and Biostatistical groups
• Conduct the defect triage meetings with cross-functional teams to prioritize the data issues.
• Perform the deep dive data analysis and identify the resolutions for the reported issues.
• Review the resolutions with cross-functional teams and incorporate the feedback.
• Fix the data in the database using database queries based on the finalized resolution strategy.
• Identify the key data attributes that are important for Clinical study using Statistical Analysis Tool (SAS).
• Work with Clinical Research organizations (External Vendors) to collect the data as per the data transfer specifications.
• Coordinating with Programming team to provide support to the data review and safety updates (coordinate generation of data review listings, data retrieval to support data review and analysis, SDTM (Study Data Tabulation Model).
• Determine the model for addressing data reconciliation
• Finalize the data reconciliation strategy

Educational and/or experience requirements:

• Bachelor’s degree of Science in Statistics/Pharmacy
• Strong experience with EDC (Rave preferred), full development life cycle
• Well-rounded technical skills: EDC, SAS, and CDISC
• Working experience handling lab/image data
• Strong understanding of clinical trials, pharmaceutical operations, and regulatory compliance
• Practical knowledge of ICH, FDA, and GCP regulations and guidelines
• Accuracy and attention to detail working with clinical data
• Good planning, project management and organizational skills

Job Type: Full-time

Salary: $100,000.00 to $120,000.00 /year

Please send profile at info@zenithlifescience.com for direct consideration or question.

-Posted on 08/16/2022

DRUG SAFETY ASSOCIATE

Department: Quality & Regulatory Compliance (Clinical Operations)

Responsibilities:

• Processing & reporting Adverse event into the Product Safety database for in association with Client’s Marketed and investigational products.
• Perform processing and oversight of adverse event/drug experience reports (serious and non-serious) and other safety related data for marketed products and clinical trials
• Responsible for Adverse event coding using standardized terminology from a medical coding dictionary, such as MedDRA
• To verifying the accuracy and completeness of information for each adverse event report for which he/she is responsible in conjunction with the source documents and ensuring that the activities are performed in a manner consistent with company SOPs.
• Assist in gathering Serious Adverse Events (SAEs) reports in a timely manner in the preparation of both internal and external IND safety reports per company SOPs.
• Process all types of adverse event reports utilizing the safety database.
• Writing case narratives for serious, non-serious and study reports, quality/product complaint reports
• Medical coding into standard dictionaries and writing of narratives based on information provided both on standard forms and from medical records and other documents of diseases and medications.
• Responsible for taking appropriate decisions by applying their knowledge of FDA & ICH-GCP standard regulations to write over all case summary.
• Assist with literature review and article procurement as required
• Generate and work with other team members to send follow up letters or queries to the appropriate reporter using the most expedient mechanism, forwarding to clinical sites where appropriate.
• Communicate/Collaborate with Medical Affairs (MA) Department in cases involving both an ADE and potential Product Quality Complaint component.
• Communicate/Collaborate with licensees, marketing partners, distributors and manufacturers in receipt and transmission of ADE reports (US and Foreign) as per applicable safety data exchange agreements.
• Interact with clinicians, nurses, pharmacists consumers, and marketing partners externally, as well as internal staff at company headquarters to get necessary missing information
• Assessment of case reports for seriousness, causality and expectedness
• Supporting the generation of aggregated safety reports and Data Monitoring Committee (DMC) reviews.
• Responsible for operational pharmacovigilance activities for assigned developmental and marketed products.
• Support the identification of corrections and creation of updates in safety database following medical review.
• Assist with Pharmacovigilance reconciliation of databases and listings (post marketing and clinical trial sources) as required
• Perform retrospective quality review and document findings, and contribute to metric compilation
• Assist with additional Drug Safety activities as required

Educational and/or experience requirements:

• A minimum degree of bachelor’s or higher degree in pharmacy or closely related field
• 1-2 years experience in Adverse Event reporting
• Hands on experience with ARGUS or ARISg
• Good Understanding of MedDRA & WHO drug dictionary

Job Type: Full-time

Salary: $60,000.00 to $70,000.00 /year

Please send profile at info@zenithlifescience.com for direct consideration or question.

-Posted on 08/15/2022

DIRECTOR OPERATIONS

Department: Administration

Director Operations drives and leads the successful execution of all operational components of a large-scale global program using strong project management, leadership and organizational skills

Responsibilities:

• Lead overall operations program/team responsible for oversee Clinical Operations, Regulatory Affairs, Compliance, Pharmacovigilance, Commercial, Marketing, Medical Affairs and Sales Teams.
• Develop high quality business strategies and plans ensuring their alignment with short-term and long-term objectives
• Accountable for operational execution to support a diverse portfolio of work across Company. Proactively addresses and manages risks and issue escalation
• Demonstrates proactive, financial stewardship of company’s clinical programs while effectively leading a large global team of individuals assigned to the program.
• Lead and motivate subordinates to advance employee engagement develop a high performing managerial team
• Oversee & Assess all operations and business activities to ensure they produce the desired results and are consistent with the overall strategy and mission
• Takes ownership and accountability for the Development/management/reconciliation of overall operations within departments of Company
• Manages projects timelines, deadlines and budgets to include negotiating contracts with
• To implement the organization’s strategic plan and lead the organization toward advancing its mission by creating new revenue sources, innovative community partnerships and strong programs
• Enforce adherence to legal guidelines and in-house policies to maintain the company’s legality and business ethics
• Analysis of financial and operational results versus forecast, plan/investigate significant variances and communicate findings to practice leaders
• Developed and recommended annual & quarterly financial objectives for the company

Educational and/or experience requirements:

• Bachelor’s degree in Business Administration, Management or related field
• MBA preferred
• Strong financial, analytical and communication skills
• Highly organized, have multi-tasking skills, and efficient in ambiguous situations
• Proven ability to succeed in a dynamic & demanding environment to meet critical deadlines
• Demonstrated ability to apply analytical skills to support the development of a business case/plan and assess financial viability

Job Type: Full-time

Salary: $110,000.00 to $130,000.00 /year

Please send profile at info@zenithlifescience.com for direct consideration or question.

-Posted on 08/15/2022

QUALITY ENGINEER

Department: Product Life cycle Management/Validation

The Quality Engineer is responsible for ensuring the product Life cycle/supply chain provides components, assemblies, and products that meet expected quality levels. The Quality Engineer works cross functionally with Operations, Engineering, and Quality Organizations, to continuously improve supplier performance by implementing process controls and develop quality assurance plans.

Responsibilities:

• Plan, develops, and executes process and test method validations (IQ, OQ, PQ, PPQ) in accordance with company and guidelines
• Responsible for practicing and assisting in ensuring company wide compliance with the Quality System procedures and requirements and lead the development of quality plans, CAPAs, supplier qualifications and support verification and validations
• Creation of Electronic Change Controls (ECOs) of Drawing, IPRs, Work instruction for initial release or doc updated Revision.
• Provide an on floor support for Inspection method records, GD & T issues in Blueprints, BOM Issues, Supplier Inspection Issues.
• Provides support on CAPA for high risk (Directly Impacted) issues.
• Coordinate inspection related activities in support of other departments’ functions and requirements including performing inspections or tests of purchased parts. Coordinate the reporting, analysis, and resolution of material non-conformance incidences including active participation in Material Review Board and other meetings as needed. Support and coordinate supplier related quality activities to ensure continued improvement. Perform inspections or tests of
• Adhere to design control procedures, general safety rules, company policies and procedures, Good Manufacturing Practices, and FDA regulations including the qualification and implementation of Document Changes Notices involving product or process changes.
• Manage the Complaint System including completion of product evaluations and investigations, ensure Complaints are evaluated and closed in a sufficient manner
• Monitor and support calibration and maintenance of all test equipment and fixtures and operation of equipment. Serve as coordinator for Calibration system. This includes issuing Purchase orders, maintaining Calibration log, coordinating calibration activities, reviewing certifications and updating calibration log.
• Conduct quality audits and develop subsequent preventive action programs, including appraisal and approval or disapproval of suppliers.

Educational and/or experience requirements:

• Bachelor’s or higher degree in Industrial / Pharmaceutical Engineering or related field
• Knowledge of Quality Systems Manual, Documentation System; QSR, MDD, CMDR, ISO14971, ISO13485:2003
• Working knowledge of ISO and applicable customer and regulatory standards
• Good Understanding of IQ/OQ/PQ/PPQ

Job Type: Full-time

Salary: $65,000.00 to $75,000.00 /year

Please send profile at info@zenithlifescience.com for direct consideration or question.

-Posted on 07/18/2022

PV SUBMISSION SPECIALIST

Department: PV (Clinical Operations)

The PV Submission Specialist, under minimal supervision, will assume the responsibility of reviewing and transmission of required individual cases safety reports (ICSRs) for submission (paper and electronic) to global regulatory agencies, business partners, affiliates and other destinations. Submission specialist will perform the reconciliation of submission dates and assist with site audit requests. Must maintain continuous knowledge and expertise of local and global requirements for safety reporting.

Responsibilities:

• Prepare global submissions. Reviews regulatory issues with supervisor, as necessary, and assists in the negotiation of submission issues with agency personnel
• Prepare local paper submissions to FDA in accordance with company processes
• Complete all on time submissions to all applicable reporting destinations
• Generate, Review, and Transmit to all schedule reports to Global Health Authorities including but not limited to FDA European Agencies, Health Canada, etc
• Generate CIOMS I form, 3500 FDA MedWatch Form or similar to global partners based on defined timelines
• Prepare CIOMS I form is a reporting form, not primarily intended for electronic exchange between databases, linking the CIOMS I form provide by ICH-FDA.
• Monitors the safety database for failed submissions
• Maintain day-to-day operations of a large paper and electronic archive.
• Verification of regulated documents via workflows within electronic document management system.
• Responsible for maintenance of all Regulatory and FDA correspondence
• Ensure compliance with corporate and departmental standard operating procedures Contributes to development of standardized practices, procedures, metrics and measures productivity and performance within PV Operations.
• Prepares safety information for submission to local PV representatives
• Planning, preparing, tracking, and archiving regulatory documents and submissions in paper and electronic format
• Process adverse event information received by the Drug Safety and Pharmacovigilance department and assist in the preparation of internal and external reports
• Follow-up with Local Safety Managers to ensure on-time submissions and request details on late submissions
• Close interaction with authoring community to track availability of deliverables
• Liaise with functional source areas to ensure documents are compliant with authoring style guide
• Collaborates with Safety Data Management, Compliance and Business Management and local PV representatives to maintain accurate reporting rules
• Verification of regulated documents via ARGUS
• Assist in the ensuring ICSR readiness for inclusion in individual and aggregate reports (PSURs, PADERs, etc.)
• Responsible for review and maintenance of reporting rules within the Argus Safety Database
• Maintain working knowledge of the regulations and processes that govern the content and maintenance of controlled documents required by the FDA and ICH.
• Configuration of Reporting rules and distribution of auto-scheduled expedited reports
• Performs oversight of the Submissions Mailbox
• Expedited report acknowledgements are monitored for successful transmission
• E2B failures are monitored and investigated immediately
• Provide training and support to newer members of the submission team

Skills Require:

• Must have sufficient experience and a demonstrated knowledge and understanding of global safety reporting regulations and guidelines including the FDA, ICH, & EU Regulations and Requirements for Pharmacovigilance
• Knowledge of the ARGUS Safety Database
• Knowledge and prior experience in case processing*
• Experience with managing vendors, partners, and/or CRO’s preferred

Educational and/or experience requirements:

• Bachelor’s or higher degree in Biology, Biotechnology or closely related field required
• Minimum of 2 years drug safety experience required
• Demonstrated proficiency in safety database functionality
• Global Drug Safety Case processing experience

Job Type: Full-time

Salary: $70,000.00 to $80,000.00 /year

Please send profile at info@zenithlifescience.com for direct consideration or question.

-Posted on 07/15/2022

PRODUCT/DRUG SAFETY COORDINATOR AND CODING SPECIALIST

Department: Quality & Regulatory Compliance (Clinical Operations)

Responsibilities:

• Processing & reporting Adverse event into the Product Safety database for in association with Client’s Marketed and investigational products.
• Perform processing and oversight of adverse event/drug experience reports (serious and non-serious) and other safety related data for marketed products and clinical trials
• Responsible for Adverse event coding using standardized terminology from a medical coding dictionary, such as MedDRA
• To verifying the accuracy and completeness of information for each adverse event report for which he/she is responsible in conjunction with the source documents and ensuring that the activities are performed in a manner consistent with company SOPs.
• Assist in gathering Serious Adverse Events (SAEs) reports in a timely manner in the preparation of both internal and external IND safety reports per company SOPs.
• Process all types of adverse event reports utilizing the safety database.
• Writing case narratives for serious, non-serious and study reports, quality/product complaint reports
• Medical coding into standard dictionaries and writing of narratives based on information provided both on standard forms and from medical records and other documents of diseases and medications.
• Responsible for taking appropriate decisions by applying their knowledge of FDA & ICH-GCP standard regulations to write over all case summary.
• Assist with literature review and article procurement as required
• Generate and work with other team members to send follow up letters or queries to the appropriate reporter using the most expedient mechanism, forwarding to clinical sites where appropriate.
• Communicate/Collaborate with Medical Affairs (MA) Department in cases involving both an ADE and potential Product Quality Complaint component.
• Communicate/Collaborate with licensees, marketing partners, distributors and manufacturers in receipt and transmission of ADE reports (US and Foreign) as per applicable safety data exchange agreements.
• Interact with clinicians, nurses, pharmacists consumers, and marketing partners externally, as well as internal staff at company headquarters to get necessary missing information
• Assessment of case reports for seriousness, causality and expectedness
• Supporting the generation of aggregated safety reports and Data Monitoring Committee (DMC) reviews.
• Responsible for operational pharmacovigilance activities for assigned developmental and marketed products.
• Support the identification of corrections and creation of updates in safety database following medical review.
• Assist with Pharmacovigilance reconciliation of databases and listings (post marketing and clinical trial sources) as required
• Perform retrospective quality review and document findings, and contribute to metric compilation
• Assist with additional Drug Safety activities as required

Educational and/or experience requirements:

• A minimum degree of bachelor’s or higher degree in pharmacy or closely related field
• 1-2 years experience in Adverse Event reporting
• Hands on experience with ARGUS or ARISg
• Good Understanding of MedDRA & WHO drug dictionary

Job Type: Full-time

Salary: $60,000.00 to $70,000.00 /year

Please send profile at info@zenithlifescience.com for direct consideration or question.

-Posted on 06/25/2022

MANUFACTURING ENGINEER

Department: Product Life cycle Management/Validation

The primary purpose of this position is to evaluate, select and apply standard engineering practices, techniques and procedures while using sound judgment when making adaptations and/or modifications to machinery, test and measurement equipment and/or systems. Ensures company’s internal and external customer expectations are met or exceeded.

Responsibilities:

• Plan, develops, and executes process and test method validations (IQ, OQ, PQ, PPQ) in accordance with company and guidelines
• Design control systems to coordinate activities and production planning in order to ensure that products meet quality standards
• Figure out how to manufacture parts or products, or deliver services, with maximum efficiency
• Development and implementation of investigations, protocols and test standards, procedures to maintain required
• Follows and develops Quality and Regulatory requirements including Company’s policies, procedures, and appropriate regulatory requirements
• Prepares or reviews documentation with a high degree of accuracy, completeness, and effectiveness using common Company’s engineering tools & templates where available, (Examples include specifications, manufacturing procedures, ECOs, and technical reports or analysis)
• Applies and promotes Lean manufacturing techniques to continuously improve cycle times and process flows. Identifies, supports, or directs the execution of improvement efforts to reduce waste in all manufacturing and business processes
• Support and Participate in the lean manufacturing cultural change to drive out waste in manufacturing processes
• Program data validation checks and listings to identify production discrepancies
• Review production schedules, engineering specifications, process flows, and other information to understand methods that are applied and activities that take place in manufacturing and services
• The beneficiary will develop a validation master plan which will document a complete list of process validation studies required for product, including the appropriate level of effort and timing of process validation activities
• Prepares or reviews documentation with a high degree of accuracy, completeness, and effectiveness using common Company’s engineering tools & templates where available. (Examples include specifications, manufacturing procedures, ECOs, and technical reports or analysis)
• Uses structured problem solving techniques and statistical methods for data driven analysis and decisions to improve production / solve problem
• The beneficiary will perform risk assessment and gap analysis of software and use gap analysis to rectify those gapes in requirements

Educational and/or experience requirements:

• Bachelor’s or higher degree in Industrial / Pharmaceutical Engineering or related field
• Working knowledge of ISO and applicable customer and regulatory standards
• Good Understanding of IQ/OQ/PQ/PPQ

Job Type: Full-time

Salary: $70,000.00 to $80,000.00 /year

Please send profile at info@zenithlifescience.com for direct consideration or question.

-Posted on 06/11/2022

MEDICAL REVIEWER

Department: PV (Clinical Operations)

Responsibilities:

• Reviews the Adverse event case narrative, coding, product/Indication, labeling in accordance with the respective reference safety documents, causality and Medical history for medical completeness, accuracy, and overall medical content.
• Analyze medical data to investigate causes and treatment of toxicity, pathogens, or chronic diseases and adverse event reaction caused due to drugs given for medication.
• To Review and provide PV therapeutic area input for development of protocols, IBs, SAPs, CSRs and other relevant project/study documents
• Review a Line Listing of cases and evaluates the coding and labelling and confirm the events are evaluated correctly.
• Manage review of cases according to internal timelines
• In conjunction with pharmacovigilance scientists and physicians contribute to writing and maintaining Risk Management Plans.
• Contribute to solving reconciliation medical coding issues/discrepancies
• Review and update generated follow-up letters for the prescribers and investigators as appropriate.
• Responsible for Company sponsored clinical trials, confirms that a case is a SUSAR case or an otherwise expeditable report which requires unblinding
• Responsible to support in preparing aggregate safety data reviews for pre-and post-marketing ASRs including Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs), Development safety Update Reports (DSURs), IND annual reports, and other Ad-hoc reports
• Liaise with marketing team(s) to evaluate safety impact and provide input into program design (e.g., social media, market research, patient support programs).
• Assist in writing and/or reviewing of monthly safety signal reports

Skills Require:

• Demonstrated qualities of competency, accountability, initiative, and leadership
• Experience in process improvement initiatives
• Extensive knowledge of US, ICH and EU PV and GCP regulations
• Excellent strategic decision-making and analytical skills
• Computer skills including proficiency in use of Microsoft Word, Excel & PowerPoint
• Strong leadership skills with excellent track record
• Strong verbal, writing and organizational skills, including good command of English
• Experience with Regulatory Authority Inspections (PV and GCP)
• Experience working with vendors

Educational and/or experience requirements:

A physician (MD or equivalent) with 3 +years pharmaceutical experience preferably performing Medical Review. Ability to critically evaluate safety data from multiple sources (clinical trials, literature, etc.), assesses clinical importance and potential strategic impact of the data and present the findings clearly in both written and oral communication is required.

Job Type: Full-time

Salary: $100,000.00 to $120,000.00 /year

Please send profile at info@zenithlifescience.com for direct consideration or question.

-Posted on 06/01/2022