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    Drug Safety Associate

    Apcer Life Sciences
    0-5 years
    Not Disclosed
    14 May 21, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, CPC Certified, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Opportunity: Drug Safety Associate

    Company: APCER Life Sciences

    Location: Jersey City, NJ, USA
    Employment Type: Full-Time
    Compensation: $100,000 to $110,000 per year
    Benefits Offered: Dental, Medical
    Company Website: APCER Life Sciences

    Why Work Here?

    Together for better health!

    Responsibilities:

    • Supervise or perform the periodic reconciliation of safety report information between the drug safety database and local PV representatives (PQC, CRO, Data Management, LSM, etc.).
    • Manage and oversee PV vendor(s) regarding intake and reconciliation activities.
    • Support the management and oversight of Case Management Mailboxes and other sources of intake for ICSR processing.
    • Support PV management in the oversight of vendor-supported ICSR intake/processing.
    • Perform and/or oversee the collection and follow-up processes of adverse event (AE) reports from clinical trials and post-marketing sources.
    • Coordinate internally and with external pharmacovigilance providers (CROs) and Business Partners on Drug Safety and Pharmacovigilance case management issues.
    • Participate in training activities related to case management.
    • Support PV Management with Call Center business-related activities (oversight, training, reconciliation).
    • Support PV management in investigation, root cause analysis, and corrective and preventive actions related to internal and external PV-associated CAPA findings.
    • Maintain a thorough understanding and strict adherence to GCP guidelines and regulatory reporting regulations.
    • Serve as PV Subject Matter Expert (SME) for associated projects/product-related meetings/committees.
    • Assist in the generation of database queries for AE listings.
    • Support technology-related projects such as safety database upgrades and the implementation of new case processing and intake tools.
    • Participate in case processing activities including triage, data entry, assessment, quality review, query generation, manufacturer notifications, and coding. Tasks may include review of source information, MedDRA coding, narrative preparation, preliminary seriousness, causality and listedness assessments, case corrections, and listing reviews.
    • Participate in User Acceptance Testing activities for Case Management initiatives.
    • Perform assigned PV-related activities in accordance with Otsuka Standard Operating Procedures and regulatory requirements.
    • Support guidance document development and updates including but not limited to PVAs, SMPs, SOPs, and other guidance/training documents.
    • Lead and provide safety operations support on assigned studies.
    • Support PV Inspection/Audit activities or Health Authority requests.

    About APCER Life Sciences:

    APCER Life Sciences is committed to improving health in partnership with its clients. We bring together safety, medical, regulatory, and technology resources to ensure that patients receive the safest, most effective therapies possible.

    Company Address:

    111 Town Square Place Suite 860
    Jersey City, NJ, USA

     

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