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Senior Drug Safety Physician
4 months ago
When our values align, there's no limit to what we can achieve.
We are looking for experienced candidates for the position of Senior Drug Safety Physician with minimum 2 Years of ICSR experience .
Location - Chandigarh/Mohali/Hyderabad/ Homebased
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.
