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    Country Safety Team Lead, South Asia

    Johnson & Johnson
    2+ years
    Not Disclosed
    Mumbai
    10 Sept. 13, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title:

    Country Safety Team Lead, South Asia

    Function: Product Safety

    Sub Function: Pharmacovigilance

    Category: Senior Principal Scientist, Pharmacovigilance (ST8)

    Location: Mumbai, Maharashtra, India

    Date Posted: Sep 10, 2024

    Requisition Number: 2406208939W

    Description: The Country Safety Team Lead for South Asia will oversee the safety activities related to medicinal products, ensuring compliance with local regulations and company policies. This role involves managing pharmacovigilance (PV) systems and ensuring adequate oversight and record management for products.

    Principal Responsibilities:

    1. Pharmacovigilance Oversight:

      • Act as the local nominated person for Pharmacovigilance (PV), including back-up responsibilities.
      • Serve as the Pharmacovigilance Officer in charge for India.
      • Oversee the PV system, ensuring compliance with regulatory reporting requirements and maintaining proper record management.
      • Collaborate with local Marketing Authorization Holders (MAH) and other stakeholders to fulfill regulatory responsibilities.

    2. Safety Management & Reporting:

      • Manage the collection, processing, and reporting of Adverse Events (AEs) and other safety information, ensuring compliance with procedural timelines and local regulatory requirements.
      • Oversee translation of safety reports and collaborate with the Case Management team for aggregate reporting and research-related activities.
      • Act as a safety expert, preparing and implementing Risk Management Plans (RMPs) and Urgent Safety Restrictions (USR) as necessary.

    3. Local Medical Safety Management:

      • Develop and maintain product knowledge to support local Medical Affairs and Marketing teams.
      • Conduct safety training for Local Operating Company (LOC) employees and oversee local safety initiatives.
      • Ensure compliance with safety-related regulations and provide insights for local protocols and safety communication.

    4. Collaboration & Support:

      • Collaborate with Regulatory Affairs and other departments to address safety-related inquiries and provide technical and strategic input.
      • Support the Qualified Person (QP) in safety-related regulatory communication and participate in Product Issue Management teams.

    5. Procedural Documentation:

      • Implement and maintain Global PV Procedural Documents and develop local procedures as needed.
      • Ensure all local PV quality documents are updated and retained according to regulatory requirements.

    6. Training:

      • Maintain a training matrix for local PV personnel and conduct training on drug safety reporting.
      • Support global rollouts and ensure compliance with local training requirements.

    7. PV Contract Management:

      • Manage local PV agreements and ensure proper implementation and adherence.
      • Maintain and update the inventory of PV agreements, including reconciliation with the agreements database.

    8. Safety Policy and Strategy:

      • Monitor and implement changes in PV regulations, and contribute to shaping local policy through industry associations.

    9. Audit & Inspection Readiness:

      • Serve as the local PV contact for audits and inspections, ensuring preparation and follow-up actions are completed as required.

    10. Business Continuity:

      • Ensure a process for reporting AEs after hours and develop a disaster recovery/business continuity plan to maintain critical PV functions.

    Qualifications:

    Essential Knowledge & Skills:

    • Strong knowledge of medicine, pharmacy, and clinical practice, with proficiency in medical terminology.
    • Proven ability to manage workflow activities and address multiple critical issues.
    • Familiarity with industry principles of drug development and pharmacology.
    • Excellent verbal and written communication skills in local languages and English.
    • Ability to negotiate and maintain relationships with internal and external stakeholders.

    Experience:

    • Significant experience in the pharmaceutical industry with a focus on pharmacovigilance.
    • Proven experience in managing safety activities and compliance with pharmaceutical regulations.

    Educational Requirements:

    • Scientific study background with experience in pharmaceutical regulations and R&D processes.

    If you are a seasoned professional in pharmacovigilance with a strong track record in safety management and compliance, we invite you to apply for this key leadership role.

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