Senior Physician, Patient Safety

reputed company our values align, there's no limit to reputed company can reputed company. At reputed company, we reputed company reputed company the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market reputed company, every clinical development solution we reputed company is underpinned by something special - a deep conviction in reputed company do. Each of us, no matter reputed company do at reputed company, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with reputed company and we're committed to making a difference. Key Requirements: Bachelor of Medicine, Bachelor of Surgery (MBBS) / Doctor of Medicine (MD) with 2+ years of experience in ICSR Medical Review Experience in pharmacovigilance and medical monitoring activities desirable but not essential Completion of at least basic training in clinical medicine (residency, internship etc.) Good knowledge/understanding of medical terminology Relevant experience in pharmacovigilance/ Drug Safety/ Clinical Practice 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 reputed company to review process with Line Manager/ Project Leader/Designee Interacting with reputed company 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 reputed company/Functional reputed company for audits and inspections Provides inputs for process improvements Works closely with Project reputed company/Functional reputed company for process co-ordination and to ensure meeting reputed company Key Performance Indicators (KPIs) for the process Function as pharmacovigilance representative/safety scientist Attend/support Bid defense meetings Actively mentoring Patient Safety Physicians to reputed company their skills and expertise Case Report Medical Review (as applicable): Performing medical review of cases not limited to (including reputed company and challenging cases requiring expert judgement)), clinical trial, and literature cases including combination products {drug-device}) according to client/reputed company Standard Operating Procedures (SOPs; as applicable) and liaising with the client, as require 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 reputed company documents, assign appropriate Medical Dictionary for Regulatory Activities (MedDRA) code, review narrative Identify and resolve case issues, coordinate with client therapeutic/legal team reputed company guidance to junior physicians on case assessment methodologies Knowledge and Experience: Experience in pharmacovigilance and medical monitoring activities desirable but not essential Education: Bachelor of Medicine, Bachelor of Surgery (MBBS) / Doctor of Medicine (MD)/ Medically reputed company from an acknowledged Medical School Apply To This Job