JOB DESCRIPTION JD Serve as the company s subject matter expert on drug safety and pharmacovigilance Ensure compliance with Local Global PV-relevant Heath Authority requirements Oversee PV Contracts vendor management and PV system audits inspections Have good understanding of signal management and benefit-risk evaluation activities Develop and implement Risk Management Plans RMPs and additional Risk mitigation measures Act as the primary safety liaison with country regulatory authorities and internal stakeholders Collaborate 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 compliance 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 Robust analytical strategic thinking and communication skills The base pay for this position is N A In specific locations the pay range may vary from the range posted JOB FAMILY Product Development DIVISION EPD Established Pharma LOCATION India Mumbai BKC Building ADDITIONAL LOCATIONS WORK SHIFT Standard TRAVEL Not specified MEDICAL SURVEILLANCE Not Applicable SIGNIFICANT WORK ACTIVITIES Continuous sitting for prolonged periods more than 2 consecutive hours in an 8 hour day

📌 Head Pharmacovigilance India (Mumbai)
🏢 Abbott
📍 Mumbai