Drug Safety Physician

Role & Responsibilities
• Provide medical review, analysis, and guidance during the case handling and reporting cycle of Adverse Event (AE) and Adverse Reaction reports for investigational and marketed products
• Conduct signal detection, analysis, evaluation, and ongoing safety surveillance activities
• Provide medical guidance and input to Drug Safety Associates (DSAs) and specialists in the medical aspects of drug safety
• Act as a pharmacovigilance representative and safety scientist
• Maintain a good working knowledge of the Adverse Event profile of assigned products, labeling documents, data handling conventions, client’s guidelines, and international drug safety regulations
• Ensure compliance with internal and regulatory timelines for adverse event reporting
• Communicate and discuss issues related to the review process with the Project Manager
• Interact with internal and external contacts to resolve issues
• Attend and present client/cross-functional meetings with other stakeholders

Case Report Medical Review
• Perform medical review of cases according to client Standard Operating Procedures (SOPs)
• Write Pharmacovigilance/Marketing Authorization Holder (MAH) comments and assess company causality
• Assess seriousness and expectedness of reported events
• Provide medical advice to the case processing team

Qualification
• MBBS or MD (Medical Doctor)

Experience
• Fresher or relevant experience in pharmacovigilance/Drug Safety is preferred

Skills
• Excellent interpersonal, verbal, and written communication skills
• Client-focused approach to work
• Flexible attitude with respect to work assignments and new learnings
• Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
• Strong knowledge of international drug regulations, including GCP (Good Clinical Practice) and GVP (Good Pharmacovigilance Practice)
• Ability to assess the clinical relevance of medical data and interpret its clinical meaning

About The Company
• Parexel – A leading global provider of biopharmaceutical services, Parexel specializes in drug development and regulatory consulting. With a focus on high-quality services and innovative healthcare solutions, Parexel works with clients to ensure the safety and efficacy of drugs across the clinical development lifecycle.