Associate Director, Pharmacovigilance Scientist
$203,837–$212,850 year
Remote · United States
Job Summary
Provide medical and scientific oversight of global drug safety activities for Beeline Medicines’ immunology/inflammation programs. Lead signal detection, benefit-risk assessments, medical case review, and aggregate safety analyses; author and oversee periodic safety reports (DSURs, PSURs/PBRERs, PADERs, line listings); collaborate with PV Operations, Clinical Development, Medical Affairs, and Regulatory to ensure rigorous, timely safety evaluations and regulatory responses. Oversee ICSR medical review, regulatory safety communications, and risk management activities; contribute to safety governance and safety labeling strategies; monitor evolving PV regulations and literature; travel as needed (up to ~10%+). Strong track record in pharmacovigilance, scientific leadership, and cross-functional collaboration; experience with DSURs/PSURs/ISS and safety signal evaluation in biologics/immunology contexts.
Required Qualifications
- 7+ years of pharmacovigilance or drug safety experience in the pharmaceutical or biotech industry with demonstrated scientific and medical expertise in safety signal evaluation and benefit-risk assessment
- Advanced degree required; PharmD, or PhD in a biomedical or clinical discipline strongly preferred
- Deep knowledge of global PV regulatory frameworks (FDA 21 CFR, EU GVP Modules, ICH E2A–E2F, MedDRA)
- Experience leading or contributing to signal detection programs (EBGM/PRR, data mining, literature reviews)
- Experience authoring DSURs, PSURs/PBRERs, and ISS for regulatory submissions
- Strong medical case review skills and ability to craft safety narratives
- Proven ability to influence across organizational boundaries and align senior stakeholders
- Excellent written and verbal communication skills for diverse audiences
- Willingness to travel domestically up to 10%+
- Ability to work in eastern time zone
- Remote work designation with periodic office visits
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