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Safety Physician

United Kingdom - CambridgePharmacovigilance & EpidemiologyRegular

Job Description

Specific Responsibilities
• Collaborates with Safety Scientists in the identification and assessment of safety signals and trends; presentation of medical safety review to product safety committees and senior management, and supports management of any potential safety issues; provides medical review of aggregate reports such as periodic safety update report (PSURs) and other periodic safety reports
• Contributes to preparation and review of safety documents in response to regulatory inquiries
• Participates in audits, data analysis, and other ad hoc activities
• Participates in both internal and external educational initiatives
• Contributes to, and may manage, a critical component of a functional or cross-functional project
• May lead and initiate functional area projects
• Participates in process improvement initiatives by identifying areas for improvement and presents solutions
• May serve as medical monitor for post-authorization safety studies
• May serve on higher level intradepartmental and interdepartmental cross-functional projects and /or clinical sub-teams when appropriate
• Participates in standard operating procedure (SOP) updates, audits, data analysis, and other ad hoc activities
• Establishes recognition as an expert on medical safety assessment of individual cases Essential Duties and Job Functions
• Provides medical safety review and/or sign off for wide variety of safety documents, both within GLPS and cross functionally, including clinical study protocols, investigator brochures (IB), clinical study reports (CSRs), reference safety information (RSI), regulatory documents, and other documents for investigational and marketed products
• Performs continuous risk/benefit evaluation throughout the lifecycle of various assigned innovative products

Knowledge, Experience and Skills
• Requires an MD/DO degree or equivalent
• Requires completion of an accredited medical or surgical residency program. Board certification is preferred
• Should have either (1) minimum of 2 years experience in a pharmacovigilance or applicable role in the pharmaceutical industry with a general understanding of relevant regulatory requirements OR (2) an exceptional track record of excellence in an area including clinical research, health administration, health policy, epidemiology, or academic or subspecialty medicine
• Demonstrates deep understanding of pharmacovigilance practices including MedDRA coding and worldwide safety regulations and guidelines
• Demonstrates an excellent scientific/clinical and analytical knowledge base, with ability to assess data and understand the safety/medical implications
• Acknowledged by cross-functional teams as internal safety and pharmacovigilance product-specific expert
• Proven ability to communicate to high level stakeholders under tight deadlines and to manage multiple major projects simultaneously
• Shows confidence and expertise in handling complex clinical and postmarketing medical safety cases, and providing medical input in risk management activities
• Demonstrates confidence in the presentation of safety reviews to safety committees and senior management
• Demonstrates the ability to handle increasing and/or changing responsibilities (e.g. team growth, integration efforts across other departments or the organization)