Senior Drug Safety Physician

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
• 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)

General:

• Maintaining a good working knowledge of the Adverse event profile of assigned products, labeling documents, data handling conventions, clients 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 reporting
• Maintaining excellent knowledge of the safety profile of assigned products
• Communicating and discussing issues related to review process with Project Manager
• Interacting with internal and external contacts for resolving issues
• Maintaining a good working knowledge of relevant regulatory guidelines
• Attend and present client/cross functional meetings along with other stakeholders
• Training and mentoring new team member, as required
• Working as Subject Matter Experts (SMEs)
• Assisting the Manager for inspection readiness activities and audits
• Provides inputs for process improvisations
• Works closely with Manger for process co-ordination and to ensure meeting all KPIs for the process.

Case report Medical Review

• Performing medical review of cases according to client Standard Operating Procedures (SOPs) and liaising with the client, as required
• Writing Pharmacovigilance/Marketing Authorization Holder (MAH) comment and assessing company causality
• Assessing seriousness and expectedness of reported events
• Providing medical advice to DSPs and case processing team
• Literature review (as applicable)
• Review of literature for product safety assessment and potential safety issues

Skills:

• Excellent interpersonal, verbal and written communication skills
• Computer proficiency, an ability to work with web-based applications and familiarity with the Windows operating system
• Client focused approach to work
• A 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
• Ability to assess the clinical relevance of medical data and to interpret its clinical meaning is essential
• Willingness to work in a matrix environment and to value the importance of teamwork
• Strong knowledge of international drug regulation including GCP, GVP

Knowledge and Experience:

• 2 Years Relevant experience in Pharmacovigilance/ drug safety is desirable.

Education:

• MBBS/Post Graduation in Medicine with relevant experience