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Greater Philadelphia Area, Maharashtra United States

Manager, Pharmacovigilance Quality and Compliance at Incyte

Medical / Health Care / Pharmaceuticals

• Highly motivated and consummate PV professional with 8 years of drug safety and compliance experience in Pfizer Inc. Bayer Health Care, Daiichi Sankyo and Incyte Corp. • Proficient in conducting RCA/CAPA of late ICSRs for overall regulatory compliance. • Sound knowledge of compliance (PV monitor) and related safety databases (ARGUS). • Master’s degree in Regulatory Affairs. • Lead and participated in various license partner audits and Health Authority PV inspections (FDA, EMEA, BfArM etc.) • Skilled in writing responses to inspection/ audit findings • Trained and supervised new case processors. • Skilled in preparing monthly compliance reports using Pivot, Vlookup and other advanced E...