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Head Pharmacovigilance India

10 years
Not Disclosed
10 Sept. 8, 2025
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: [Insert Title – e.g., Head/Director of Pharmacovigilance]
Location: [Insert Location]
Department: Pharmacovigilance / Drug Safety
Reports To: [Insert Reporting Manager/Designation]


Job Summary

The [Job Title] will serve as the company’s subject matter expert (SME) in drug safety and pharmacovigilance (PV). The role is responsible for ensuring compliance with local and global PV regulatory requirements, overseeing safety operations, and driving risk management strategies. This position involves cross-functional collaboration, leadership of PV teams, and strategic engagement with health authorities and internal stakeholders to maintain the highest standards of patient safety and regulatory compliance.


Key Responsibilities

Pharmacovigilance Expertise & Compliance

  • Serve as the company’s SME on drug safety and PV.

  • Ensure compliance with local and global PV-related health authority requirements.

  • Act as the primary safety liaison with regulatory authorities and internal stakeholders.

Safety Operations & Risk Management

  • Oversee PV contracts, vendor management, and PV system audits/inspections.

  • Contribute to clinical trial safety strategies and documentation (protocols, safety monitoring plans, SAE reporting, etc.).

  • Lead signal detection, signal management, and benefit–risk evaluation activities.

  • Develop and implement Risk Management Plans (RMPs) and additional risk mitigation measures.

Leadership & Collaboration

  • Collaborate with Clinical Development, Regulatory Affairs, Medical Affairs, Quality Assurance, and Marketing teams to ensure integrated safety strategies.

  • Mentor, train, and develop PV team members to foster a culture of compliance and continuous improvement.

  • Manage departmental budgets, staffing, and resourcing in alignment with organizational needs.


Qualifications & Experience

  • Advanced degree in Medicine (MD/MBBS) or Pharmacy (PharmD/M.Pharm).

  • Minimum 10 years of progressive experience in pharmacovigilance within the pharmaceutical industry.

  • In-depth knowledge of local and global PV regulations and guidance.

  • Proven track record in leadership roles with the ability to build, scale, and optimize PV systems.

  • Strong analytical, strategic thinking, and communication skills.