Drug Safety Physician
7 days ago
**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, 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, 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 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
**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 case processing team
**Literature review**
- Review of literature for product safety assessment and potential safety issues
**Skills**:
- Excellent interpersonal, verbal and written communication skills
- Review of literature for product safety assessment and potential safety issues
- 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**:
Good knowledge of medical terminology.
Fresher/ relevant experience into pharmacovigilance/ Drug Safety field is preferred.
**Education**:
Graduation/Post Graduation in Medicine.
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