Drug Safety Physician

7 days ago

Delhi Delhi, India Parexel Full time

**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
- 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

**Skills**:

- Excellent interpersonal, verbal and written communication skills
- 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**:
MBBS/MD

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