Parexel- Senior Drug Safety Physician Jobs – MBBS Candidates Apply Now
Parexel, a global leader in clinical research and consulting for the pharmaceutical and healthcare industry, is hiring a Senior Drug Safety Physician. This prestigious role focuses on ensuring drug safety through expert medical review and pharmacovigilance. With an emphasis on improving patient health outcomes, this opportunity is ideal for experienced medical professionals looking to make a global impact in clinical safety and regulatory excellence.
- 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 the 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 the review process with the 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 members, as required
- Working as Subject Matter Experts (SMEs)
- Assisting the Manager with inspection readiness activities and audits
- Provides inputs for process improvements
- Works closely with the Manager for process coordination and to ensure meeting all KPIs for the process
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 concerning work assignments and new learning
- Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
- The 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 of Relevant experience in Pharmacovigilance/drug safety is desirable
- Education: MBBS/Post Graduation in Medicine with relevant PV experience
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