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

• 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

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.

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:

• 3 Years Relevant experience in PBRER/Signal.

Education:

• MBBS/Post Graduation in Medicine with relevant experience.