Pharmacovigilance Physician

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as a Pharmacovigilance Physician – Make an Impact at the Forefront of Innovation At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future. The Pharmacovigilance Physician provides medical oversight of pharmacovigilance activities to ensure company SOPs, client directives, good clinical practice, and regulatory requirements are followed. Attends and presents at sponsor meetings, provides medical and pharmacovigilance consultation to clients and project team members. May also support business development activities. Provides medical review and analysis for clinical trial serious adverse events, marketed products ICSR with focus on triage, seriousness, expectedness, causality assessment, appropriate selection of adverse event terms using MedDRA terminology, narrative review and periodic safety reports (e.g. PBRER, PSUR, DSUR) as well as other client deliverables (e.g. labeling reconciliation documents, CTD modules, REMS, RMP, and CSR). Identifies and investigates safety signals and contributes to the management of the benefit-risk profile of assigned products. We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. What You'll Do: Manage all medical aspects of contracted pharmacovigilance tasks across the pharmaceutical product life cycle. Adhere to applicable regulations and ICH guidelines regarding clinical trials, regulatory documents, and safety issues, as well as client SOPs/directives, project-specific WPDs for assigned projects, and the organization’s corporate policies and SOPs/WPDs. Provide medical consultation to team members and communicate clearly with associates and clients, maintaining an open line of communication to ensure all procedures are followed appropriately. Provide therapeutic and protocol training on assigned studies, as requested. Assist in writing (interpretation of safety data) and/or reviewing the safety portion of the CSR, IND/NDA report, ICSR, signal detection reports, periodic reports, RMP, REMS, CTD modules; scientifically review aggregate reports, contribute to label updates, review and assess literature, and support dossier maintenance and risk management activities to ensure that the medical content is accurate and complete. Provide medical review of cases and perform reviews of adverse events of special interest and serious adverse events. Perform data reviews as specified in the client contract and data validation manual, including review of coding listings and/or full safety data to assess potential safety concerns. Medically review adverse event and serious adverse event data from all sources (solicited, spontaneous, literature, etc.) as contracted. Education and Experience Requirements: Must be MD or equivalent or MBBS qualified graduate 5+ Years of experience in pharmaceutical/biotech industry with at least 2 years in pharmacovigilance/drug safety (global experience is a plus) Experience in clinical practice or in academic medicine is a plus Working knowledge of relevant pharmacovigilance regulatory requirements and guidance documents Demonstrated ability to perform medical assessments of safety data from multiple sources Experience with authoring complex documents and contributing to regulatory submissions Knowledge of adverse event reporting systems Experience in epidemiology, biostatistics, clinical development, or medical affairs is a plus Knowledge, Skills, Abilities: Clinical expertise with attention to detail, quality and patient safety Candidate should have at least 2+ years of experience in Pharmacovigilance medical review activities. Excellent medical knowledge of physiology and pharmacology, understanding of clinical study objectives and overview of the complete drug development process Great multi-tasking abilities, technical, analytical, organizational and problem-solving skills, excellent oral and written communication skills, and presentation skills Ability to work independently and under pressure, analyze work with attention to detail, process and prioritize sensitive complex information Proficiency in basic computer applications Fluent in spoken and written English Excellent interpersonal, influencing and team building skills Good understanding of FDA, ICH, EMA and GCP guidelines Working knowledge of relevant safety databases, MedDRA, biostatistics, data management, and clinical operations procedures Ability to act as a mentor/trainer to other staff Working Environment: Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role: Work is performed in an office environment with exposure to electrical office equipment. Occasional drives to site locations with occasional travel both domestic and international Why join us? When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference. Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. #J-18808-Ljbffr ThermoFisher Scientific