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 PV experience.