JD:

Serve as the company’s subject matter expert on drug safety and pharmacovigilanceEnsure compliance with Local & Global PV-relevant Heath Authority requirementsOversee PV Contracts, vendor management and PV system audits/inspectionsHave good understanding of signal management and benefit-risk evaluation activitiesDevelop and implement Risk Management Plans (RMPs) and additional Risk mitigation measuresAct as the primary safety liaison with country regulatory authorities and internal stakeholdersCollaborate with Clinical Development, Regulatory Affairs, Medical Affairs, and Quality Assurance, marketing teams etc.Contribute to clinical trial safety strategies and protocols (e.g., protocols, safety monitoring plans, SAE reporting etc.)Mentor and develop PV team members to maintain a culture of continuous improvement and complianceManage departmental budgets, staffing, and resourcing in line with organizational needs

Qualifications:

Advanced degree in Medicine or PharmacyMinimum 10 years of progressive pharmacovigilance experience in the pharmaceutical industryIn-depth understanding of Local/global PV regulations and guidanceDemonstrated experience in leadership roles with proven ability to build and scale PV systems.Strong analytical, strategic thinking, and communication skills.