Job title: Senior Drug Safety Physician
Company: Parexel
Job description: Job Purpose: * Provide medical review, analysis and guidance during the case handling and reporting cycle of Adverse Event and Adverse Reaction reports received for investigational and marketed products * Signal detection/analysis/evaluation an
Job Purpose: Provide medical review, analysis and guidance during the case handling and reporting cycle of Adverse Event and Adverse Reaction reports received for investigational and marketed products Signal detection/analysis/evaluation and ongoing safety surveillance activities Provide medical guidance and input to Drug Safety Associates (DSAs) and specialists in medical aspects of drug safety Provide medical advice/input for narratives written for Clinical Study Reports (CSRs) Provide medical, safety input and review of all required safety reports, such as- but not limited to Periodic Safety Update Reports (PSURs)/ Periodic Benefit Risk Assessment Reports (PBRERs)/Periodic Adverse Drug Experience Reports (PADERS), Risk Management Plans (RMPs), Benefit Risk Assessment, Safety Evaluation Reports (SERs), Clinical Overview (COs), Clinical Expert Statement, Investigator notification letters Function as pharmacovigilance representative/safety scientist Knowledge and Experience: Relevant experience in Pharmacovigilance/ drug safety is desirable. Experiences into relevant field is preferred. Education: Graduation/Post Graduation in Medicine. Job Location – Chandigarh/Mohali/Hyderabad/Homebased #LI-REMOTE
Expected salary:
Location: India
Job date: Sat, 15 Oct 2022 22:53:33 GMT
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