Role Summary
Director/Senior Director of Pharmacoepidemiology to lead safety-focused epidemiologic analyses within cross-functional Development and Submission Teams. Primary accountability for development and oversight of post-authorization studies to fulfill regulatory commitments involving observational study data.
Responsibilities
- Designs, produces and oversees protocols for observational studies using secondary data or primary data collection, including company-sponsored or other data sources
- Oversee timely and appropriate development of epidemiological sections of regulatory documents for agencies worldwide (e.g., Risk Management Plan, orphan or breakthrough designations, Pediatric Investigation Plan, query responses, advisory committee briefing documents)
- Contributes to Risk Management Plans (RMP, PV Plans etc) for products throughout lifecycle
- Performs systematic epidemiologic literature reviews and summaries for relevant safety topics
- Performs signal detection analyses of safety reporting system databases (AERS, Vigibase) using data mining software
- Actively participates including making presentations at meetings including product safety team and Global Patient Safety staff meetings
- May supervise 3rd parties e.g., vendors or contract/other staff
- Supports PV System implementation and maintenance and other Departmental goals and objectives
Qualifications
- Doctoral degree e.g., PhD or Master’s degree in Epidemiology from an accredited institution
- Minimum of 10 years relevant work experience, preferentially in the Pharmaceutical/Biotechnology industry with a primary focus on epidemiology evidence generation, especially for clinical development support, regulatory submissions and safety
- Solid knowledge of study methodology in general medicine and clinical practice, evidenced by experience in designing/conducting epidemiology studies, including Registries
- Strong knowledge and experience in Global Pharmacovigilance guidelines, Risk Management and regulations; knowledge of international PV regulations is a plus
- Experience with data mining software and applications
- Demonstrated ability to function with a high level of autonomy and develop productive cross-functional collaborations
- Ability to manage priorities, resources, and performance targets, in a changing environment
- Ability to communicate proactively with others across functions to ensure shared purpose and clear accountability for future decisions