GENERAL POSITION SUMMARY
Director, Safety and Benefit-Risk Management will provide strategic and clinical leadership for all safety-related activities for investigational and/or marketed products, including the continuous assessment of their safety and benefit-risk profile.

GENERAL RESPONSIBILITIES AND REQUIRED SKILLS

• Broad knowledge of medicine and relevant regulations
• Extensive evidence of effective delivery of high quality safety relevant documents, including IB, ICFs, Protocols, CSRs, DSURs, PSUR/PBRERs, Signal Evaluation Reports, Briefing documents
• Broad knowledge of relevant concepts in data management and systems, pharmacoepidemiology and statistics, including the interpretation of complex data and information
• Effectively communicates in written and spoken English
• Communicates complex issues in an understandable, effective and relevant manner.
• Strong influencing skills with the ability to explain and defend positions regarding significant issues in the face of opposition
• Strategic focus regarding activities, with proactive planning and prioritization skills.
• Effective leader and team member
• Takes ownership of appropriate issues and appropriately delegates
• Technical expertise in pharmacovigilance and clinical safety
• Excellent analytical and problem solving skills, with sound autonomy and applied judgment
• Provide effective and relevant review of complex documents

KEY RESPONSIBILITIES

• Provides medical safety expertise, state of the art pharmacovigilance, and safety risk management for  assigned products (marketed and/or in development)
• Optimizes patient safety of company’s products and maintenance of compliance with the Pharmacovigilance regulations of Regulatory Agencies around the globe through the effective and timely completion of Safety activities through the product life cycle
• Responsible for the safety assessment activities of assigned products
• Autonomously monitors the benefit risk profile of assigned products/portfolio in an ongoing fashion and in accordance GPS processes and procedures
• Lead the safety and risk management processes including chairing assigned Disease-area Safety and Product Safety Teams
• Lead the development of safety-related responses to Safety queries from health authorities
• Identify, prioritize and analyze clinical safety signals, in accordance with GPS procedures
• Perform ongoing review of emerging safety data from various sources including single case reports, published literature, aggregate reports, and other sources
• Represent department as medical safety lead on cross-functional study and program teams for assigned products and studies, providing expert guidance regarding safety matters and issues
• Conduct medical evaluation of relevant safety-related information from Toxicology, Non-Clinical studies, as well as Product Quality complaints, as needed
• Participate in protocol development, specifically the monitoring and collection of safety information in clinical trial protocols, as well as statistical analysis plans
• Participate in the analysis of safety data from on-going and completed clinical trials and representation in Clinical Study Reports
• Effectively contribute to preparation and review of periodic reports (DSUR, PSUR, PADER) contributing medical strategy and expertise to content, authoring applicable analysis and content
• Review and provide medical content, as needed, for key study-related documents, e.g. IB, ICF, IDMC Charter
• Participate in departmental development activities including SOP and Work Instructions development
• Provide guidance to staff regarding optimal practice regarding collection, evaluation and processing of adverse experience reports, from a medical perspective
• Provide a contributory role in Partner/Affiliate agreements and interactions, as needed
• Other activities, as needed or as requested by GPS management

Minimum Qualifications

• MD degree or equivalent (e.g., DO or MB) required
• At least 3-5 as Director & 10+ years relevant Safety/Pharmacovigilance experience
• Appropriate experience with Regulatory Agency and key stakeholder interactions
• Experience with ICSR case review and Aggregate Safety analysis and reports
• Experience with key Global PV/Regulatory approval activities, including NDA/MAA, RMP and REMS