Senior Physician, Patient Safety

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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)

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