Director of Risk Management
12 hours ago
Lundbeck is a global biopharmaceutical company that has been dedicated to improving the lives of people with neurological and psychiatric diseases for over 70 years. Our mission is to advance brain health and transform lives.
Job SummaryThis position is responsible for strategically managing the safety surveillance and risk minimization activities for assigned products throughout their life cycle. The incumbent will have a strong background and experience in pharmacoepidemiology principles, with a good understanding of the methodologies in leveraging real-world data to enhance patient safety.
ResponsibilitiesMain Objectives- Designing safety evidence generation and patient-centric risk minimization strategies.
- Planning and interpretation of safety data analyses and advancing methodologies in line with healthcare trends.
- Providing medical safety input into the design and conduct of pharmacoepidemiology and observational studies.
- Chairing multi-disciplinary safety committees for assigned products.
- Developing response strategies in collaboration with safety committee members, providing medical-scientific input to regulatory documents for safety-related requests from health authorities and other external parties.
- Safety data generation, developing analysis strategies, and drawing scientifically sound conclusions based on review of various data sources for signal detection.
- Risk Management:
- Drives risk minimization strategies and takes accountability for the medical-scientific content in the Risk Management Plans, including risk minimization measures, risk minimization action plans (RiskMAPS), and REMS programs, as relevant.
- Supports the implementation of a measurement of effectiveness of additional risk minimization measures and REMS.
- Designated lead on behalf of GPS-US as SME for risk management and REMS during all inspection activities from regulatory agencies as well as internal audits by R&D Quality.
- Accredited MD/DO (MBBS, MBCHb, MBBCh) degree.
- 5+ years of drug safety experience in a biotech or pharmaceutical company.
- Ability to drive drug safety evidence generation and risk mitigation strategies in a highly complex internal and external environment.
- Solid understanding of aggregate data analysis and scientific methodologies for signal detection.
- Excellent analytical skills and ability to synthesize large amounts of data and make sound medical interpretations of data.
- Good working knowledge of local and global regulations/guidelines in pharmacovigilance and risk management.
Lundbeck offers a comprehensive benefits package to help employees live well and protect their health, family, and everyday life. Benefits include flexible paid time off, health benefits, and a company match 401(k).
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