Senior Drug Safety Physician
India, Remote求人ID R0000033564 Category Medical Sciences
About this Role
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
- 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
- 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 (as applicable)
- 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
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:
- Relevant experience of minimum 2 Years in Pharmacovigilance/ drug safety is desirable.
Education:
- MBBS/Post Graduation in Medicine.
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