Clinical Director for Global Patient Safety
1 month ago
Lifelancer is a talent-hiring platform connecting professionals with opportunities in pharma, biotech, health sciences, and IT. We are seeking a skilled Clinical Director to join our team.
Job SummaryThe successful candidate will oversee the safety profile of assigned Lundbeck products according to FDA and global regulatory Pharmacovigilance guidelines. They will have a strong background in analyzing 'Big Data,' leveraging real-world data to support and enhance PV activities, and maintaining oversight of safety-related post-approval commitments.
Key Responsibilities- Medical Review and Assessment of Individual Case Safety Reports (ICSRs): Ensure medical accuracy, completeness, and quality of post-marketing and clinical trial ICSRs.
- Aggregate Reports: Responsible for reviewing the overall safety profile and risk/benefit ratio of Lundbeck products and drug candidates.
- Signal Management: Develop analysis strategies, draw scientifically sound conclusions based on review of various data sources for signal detection.
- Risk Management: Maintain oversight of risk management activities and REMS programs for assigned products.
- Accredited MD/DO (MBBS, MBChB, MBBCh) degree
- 5+ years of experience in drug safety, preferably in a biotech or pharmaceutical company
- Ability to drive drug safety evidence generation and risk mitigation strategies
- Excellent analytical skills and ability to synthesize large amounts of data
- An estimated salary range of $240,000 - $280,000 per year, with eligibility for a 25% bonus target
- Eligibility for participation in the company's long-term incentive plan
- Flexible paid time off (PTO), health benefits, and a 401k matching program
We offer a comprehensive benefits package to help employees live well and protect their health, family, and everyday life. Information regarding our benefit offering can be found on the U.S. career site.
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