Patient Safety and Pharmacovigilance

Result oriented and accuracy-driven Patient Safety and Pharmacovigilance professional with an 11+ years of experience in academics and Pharmaceutical Industry. Having a robust understanding on Patient Safety aspects and Pharmacovigilance with an extensive knowledge in patient-centered pharmaceutical care, evidence-based guideline development, population health, health services research and public speaking. Possess excellent oral and written communication skills, able to handle multiple projects simultaneously, and meet tight deadlines. Pharmacovigilance Expert with comprehensive experience in : - Global Pharmacovigilance & QPPV - Medical and scientific information handling - Review of Scientific literature - Aggregate reports, signal detection & management - Clinical and safety labeling updates (CSRs, IB update, USPI, SmPC, ICFs) - Protocol Amendments - Project management - Strong decision maker - External and Internal PV Audits - Regulatory Risk Assessment - Regulatory affairs - Drug Safety - Medical Writing - Clinical Pharmacy Services - Business Development - Medical Liaison - Quality Control - Clinical development - Medical affairs - Health Safety and Risk Management. - Launch Experience - Excellent IT skills. (IT Savvy)