Senior Drug Safety Physician – Parexel Careers | Apply Now
Looking to advance your career in pharmacovigilance and drug safety? Parexel, a global leader in pharmaceutical services, is hiring a Senior Drug Safety Physician to ensure regulatory compliance, adverse event monitoring, and clinical safety. This remote role in India (Mohali) is an exciting opportunity for experienced professionals in medical sciences and drug development.
About Parexel
Parexel is a global leader in pharmaceutical services, specializing in drug development, clinical research, and healthcare solutions. With a strong focus on pharmacovigilance, regulatory compliance, and safety monitoring, Parexel ensures that pharmaceutical products meet high safety and efficacy standards. Whether you’re an aspiring professional or an industry expert, Parexel offers exciting career opportunities in the dynamic world of clinical research and drug safety.
About the Role
Job Role: Senior Drug Safety Physician
Location: India-Mohali-Remote
Job ID: R0000031053
Category: Medical Sciences
Job Purpose:
- Provide medical review, analysis, and guidance during the case handling and reporting cycle of Adverse Events 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 Responsibilities
- Maintain a good working knowledge of the adverse event profile of assigned products, labeling documents, data handling conventions, client guidelines and procedures, and international drug safety regulations
- Maintain awareness of global regulatory requirements and reporting obligations and organize workload to ensure compliance with internal and regulatory timelines for adverse event reporting
- Communicate and discuss issues related to the review process with the Project Manager
- Interact with internal and external contacts to resolve issues
Case Report Medical Review
- Perform medical review of cases according to client Standard Operating Procedures (SOPs) and liaise with the client, as required
- Write Pharmacovigilance/Marketing Authorization Holder (MAH) comment and assess company causality
- Assess the seriousness and expectedness of reported events
Literature Review (as applicable)
- Review literature for product safety assessment and potential safety issues
Skills
- Excellent interpersonal, verbal, and written communication skills
- Computer proficiency, ability to work with web-based applications, and familiarity with the Windows operating system
- Client-focused approach to work
- Flexible attitude towards work assignments and new learnings
Knowledge and Experience
- 2 years of relevant experience in Pharmacovigilance/drug safety is desirable
- Education: MBBS/Post Graduation in Medicine with relevant PV experience
Keywords: Parexel job, drug safety physician, medical sciences, pharmacovigilance, GCP, GVP
