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Abbott - Head - Pharmacovigilance

Abbott - Head - Pharmacovigilance

Abbott Healthcare Pvt. Ltd.Mumbai, India
30+ days ago
Job description

Key Responsibilities :

  • Act as the company's SME for drug safety and pharmacovigilance, ensuring compliance with local and global PV regulations.
  • Oversee PV contracts, vendor management, and PV system audits / inspections.
  • Lead activities in signal management, benefit-risk evaluations, and safety data assessments.
  • Develop and implement Risk Management Plans (RMPs) and additional risk mitigation strategies.
  • Serve as the primary safety liaison with country regulatory authorities and internal stakeholders.
  • Collaborate cross-functionally with Clinical Development, Regulatory Affairs, Medical Affairs, Quality Assurance, and Marketing teams.
  • Contribute to clinical trial safety strategies and documentation (protocols, safety monitoring plans, SAE reporting, etc.).
  • Mentor, guide, and develop PV team members, fostering a culture of continuous improvement, compliance, and knowledge sharing.
  • Manage departmental budgets, staffing, and resourcing in line with organizational needs.

Qualifications & Experience :

  • Advanced degree in Medicine (MD) or Pharmacy (PharmD / MPharm).
  • 10+ years of progressive pharmacovigilance experience within the pharmaceutical industry.
  • Strong expertise in local and global PV regulations and guidelines.
  • Demonstrated experience in leadership roles, with proven ability to build, scale, and optimize PV systems.
  • Proficiency in signal detection, risk-benefit analysis, and RMP development.
  • Excellent analytical, strategic thinking, leadership, and communication skills.
  • (ref : iimjobs.com)

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    Pharmacovigilance • Mumbai, India

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