Pharmacovigilance Physician

Overview

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.
• 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
• Clinical expertise with attention to detail, quality and patient safety
• Excellent medical knowledge of physiology and pharmacology, understanding of clinical study
• Great multi-tasking abilities, technical, analytical, organizational and problem-solving skills, excellent
• Ability to work independently and under pressure, analyze work with attention to detail, process and

Education and Experience Requirements:

Knowledge, Skills, Abilities:

Candidate should have at least 2+ years of experience in Pharmacovigilance medical review activities.

objectives and overview of the complete drug development process

oral and written communication skills, and presentation skills

prioritize sensitive complex