JOB PURPOSE

Within the Global Pharmacovigilance (GPV) organization, under the direction of the Signal Management Team Head, the Signal Management Expert (SME) will provide scientific leadership and/or people management leadership within the Signal Management Team. The incumbent is responsible for educating stakeholders on the use of state-of-the-art signal detection methodologies, signal management processes and tools. 

The SME is responsible for providing strategic support, training, and expertise for the development and maintenance of excellence in the Signal Management component of activities and works in close collaboration with Global Safety Officers (GSO), Local Safety Officers (LSO), PV Scientists (PVS), Therapeutic Area Heads (TAH), and the GBU PV Heads in implementing a consistent signal management process across all GBU PV areas.

PROFILE 

Knowledge and Skills

• Expert in principles, theories, and practices of signaling research methods, techniques, data sources, surveillance methodologies and tools, applicable laws, rules, regulations, policies and procedures regulating the pharmaceutical industry, in addition to a general knowledge of the therapeutic areas and products
• Prior experience of independently leading complex cross-functional projects
• Sound understanding of GVP Module IX and other signal detection and management guidance
• Ability to compose and produce technical or scientific reports, documents and related material
• Make decisions or solve problems by using logic to identify key facts, explore alternatives, and propose quality solutions consistent with company policies and regulatory requirements; Monitor or track information and data
• Experience working with vendors, especially for Pharmacovigilance services
• Providing oversight to vendors performing PV activities, using knowledge of the relevant processes and medical judgment as needed
• Strong oral and written communications skills, including presentations and publications. Ability to influence stakeholders across GPV and outside of GPV
• Excellent meeting facilitation skills to achieve consensus among diverse stakeholder groups
• Excellent teamwork and interpersonal skills

Basic Qualifications

• A baccalaureate degree in a medical science is required. Additional advanced degree (MS, MSc, MSN, PharmD, etc.) or a degree with a concentration in public health is preferred
• At least 10 years of pharmaceutical/healthcare related industry experience
• Global experience in signal detection science with at least 4 years of signaling work experience preferred
• Project leadership experience, managing complex projects is preferred
• Significant and demonstrable working knowledge of pharmacovigilance regulations and guidelines, including US, ICH and EU regulations
• Experience working with vendors, particularly for pharmacovigilance activities, providing process-related and/or medical oversight is preferred
• Knowledge of external sources of DM (e.g. FDA-FAERS, WHO-Vigibase, and EudraVigilance, etc.) is preferred
• Knowledge of commonly used data mining methods and algorithms in pharmacovigilance for. both internal and external safety databases
• Experience working with internal/company global safety databases

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