Job title: Principal Drug Safety Physician
Company: Parexel
Job description: Job Purpose: Principal Safety Physician is responsible for performing medical & safety monitoring tasks in the assigned projects and contribute to medical review, analysis and guidance in all required safety reports. Principal Safety Physician is als
Job Purpose: Principal Safety Physician is responsible for performing medical & safety monitoring tasks in the assigned projects and contribute to medical review, analysis and guidance in all required safety reports. Principal Safety Physician is also responsible for providing medical leadership and subject-matter expertise to project teams, business development and pre-award activities. Job Description 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, 05 Nov 2022 23:44:47 GMT
Apply for the job now!