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Drug Safety Physician

3 months ago

Chandigarh, Chandigarh, India Parexel Full time

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 productsSignal detection/analysis/evaluation and ongoing safety surveillance activitiesProvide medical guidance and input to Drug Safety associates (DSAs) and specialists in medical aspects of drug safetyProvide medical advice/input for narratives written for Clinical Study Reports (CSRs)Provide medical, safety input and review of all required safety reports, Benefit Risk Assessment, Safety Evaluation Reports (SERs), Clinical Overview (COs), clinical Expert Statement, Investigator notification lettersFunction as pharmacovigilance representative/safety scientistGeneral:Maintaining a good working knowledge of the Adverse event profile of assigned products, labeling documents, data handling conventions, client's guidelines and procedures, and international drug safety regulations Maintaining an awareness of global regulatory requirements and reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reportingMaintaining excellent knowledge of the safety profile of assigned productsCommunicating and discussing issues related to review process with Project ManagerInteracting with internal and external contacts for resolving issuesMaintaining a good working knowledge of relevant regulatory guidelinesAttend and present client/cross functional meetings along with other stakeholdersCase report Medical reviewPerforming medical review of cases according to client Standard Operating Procedures (SOPs) and liaising with the client, as requiredWriting Pharmacovigilance/Marketing Authorization Holder (MAH) comment and assessing company causalityAssessing seriousness and expectedness of reported eventsProviding medical advice to case processing teamLiterature reviewReview of literature for product safety assessment and potential safety issues

Skills:

Excellent interpersonal, verbal and written communication skillsReview of literature for product safety assessment and potential safety issuesComputer proficiency, an ability to work with web-based applications and familiarity with the Windows operating systemClient focused approach to workA flexible attitude with respect to work assignments and new learningsAbility to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detailAbility to assess the clinical relevance of medical data and to interpret its clinical meaning is essentialWillingness to work in a matrix environment and to value the importance of teamworkStrong knowledge of international drug regulation including GCP, GVPKnowledge and Experience: Good knowledge of medical terminology. Fresher/ relevant experience into pharmacovigilance/ Drug Safety field is preferred. Education: Graduation/Post Graduation in Medicine.