When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Key Requirements:
- MBBS or MD from a recognized medical school
- 2+ years of experience in ICSR medical review
- Good understanding of medical terminology
- Experience in pharmacovigilance, drug safety, or clinical practice
- Basic clinical training (internship/residency completed)
Key Accountabilities:
General:
- Maintaining a good working knowledge of the Adverse event/Safety profile of assigned products, labeling documents, data handling conventions, client’s guidelines and procedures, and global drug safety regulations and guidelines
- Maintaining an awareness of global regulatory requirements, reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting
- Communicating and discussing issues related to review process with Line Manager/ Project Leader/Designee
- Interacting with internal and external stakeholders for resolving issues
- Attending and/ or presenting at client/cross functional meetings along with other stakeholders.
- Working as Subject Matter Experts (SMEs)
- Assisting the Project Lead/Functional Lead for audits and inspections
- Provides inputs for process improvements
- Works closely with Project Lead/Functional Lead for process co-ordination and to ensure meeting all Key Performance Indicators (KPIs) for the process
- Function as pharmacovigilance representative/safety scientist
- Attend/support Bid defense meetings
- Actively mentoring Patient Safety Physicians to develop their skills and expertise
Case Report Medical Review (as applicable):
- Perform medical review of cases, including complex and challenging cases requiring expert judgment, covering clinical trial, literature, and combination product (drug-device) cases according to client/Parexel Standard Operating Procedures and liaising with the client, as required.
- Writing Pharmacovigilance/Marketing Authorization Holder (MAH) comment and assessing company causality
- Review appropriateness of medical content in narrative for medical coherence
- Assessing seriousness, listedness / expectedness of reported events.
- Providing medical inputs to case processing team
- Raising appropriate follow-up queries for relevant information from the reporter/HCP (Health Care Professional)
- Review and verify appropriate selection of adverse events from source documents, assign appropriate Medical Dictionary for Regulatory Activities (MedDRA) code, review narrative
- Identify and resolve case issues, coordinate with client therapeutic/legal team
- Provide guidance to junior physicians on case assessment methodologies
Knowledge & Experience:
- Experience in pharmacovigilance and medical monitoring (desirable)
