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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