Head Pharmacovigilance India

As the companys subject matter expert on drug safety and pharmacovigilance, you will be responsible for ensuring compliance with Local & Global PV-relevant Heath Authority requirements. Your role will involve overseeing PV Contracts, vendor management, and PV system audits/inspections. Additionally, you will develop a good understanding of signal management and benefit-risk evaluation activities. You will be expected to develop and implement Risk Management Plans (RMPs) and additional Risk mitigation measures. Acting as the primary safety liaison with country regulatory authorities and internal stakeholders will be a key part of your responsibilities. Collaboration with Clinical Development, Regulatory Affairs, Medical Affairs, Quality Assurance, marketing teams, etc., will also be essential. Your contribution to clinical trial safety strategies and protocols, including protocols, safety monitoring plans, and SAE reporting, will be crucial. Moreover, mentoring and developing PV team members to maintain a culture of continuous improvement and compliance will be part of your role. You will also manage departmental budgets, staffing, and resourcing in line with organizational needs. Qualifications: - Advanced degree in Medicine or Pharmacy - Minimum 10 years of progressive pharmacovigilance experience in the pharmaceutical industry - In-depth understanding of Local/global PV regulations and guidance - Demonstrated experience in leadership roles with proven ability to build and scale PV systems - Strong analytical, strategic thinking, and communication skills.,