Associate Director, Pharmacovigilance Scientist

Job Summary:

The Associate Director, Pharmacovigilance Scientist is a medically and scientifically trained pharmacovigilance professional responsible for providing expert scientific and medical oversight of the company's global drug safety activities. This role conducts and oversees signal detection, benefit-risk assessment, medical case review, and aggregate safety analyses in support of the company's I&I clinical programs and post-marketing safety obligations. The Associate Director partners with PV Operations, Clinical Development, Medical Affairs, and Regulatory Affairs to ensure that safety information is evaluated rigorously, communicated clearly, and acted upon in a timely and compliant manner.

Work Arrangement & Location: 

Remote - This position is designated as remote; the incumbent will be expected to travel to Beeline Medicines’ offices on a periodic basis to support in-person collaboration, team engagement, and business operations. The frequency and scheduling of such visits will be determined at the company's discretion based on business need.

Essential Duties and Responsibilities:

• Serve as the scientific and medical expert for pharmacovigilance activities across the company's I&I pipeline, providing medical case review and clinical assessment of individual adverse event reports and aggregate safety data.
• Lead and oversee signal detection activities, including routine data mining of the safety database, evaluation of disproportionality analyses, and systematic literature review for emerging safety signals.
• Conduct benefit-risk assessments for emerging safety signals and contribute to regulatory responses, labeling updates, and risk management strategies based on scientific evaluation.
• Author and oversee the scientific content of periodic safety reports, including DSURs, PSURs/PBRERs, PADERs, and line listings, ensuring accurate medical interpretation of safety data.
• Review and provide medical oversight of ICSRs, including complex and medically significant cases, ensuring narrative quality, appropriate medical coding, and regulatory compliance.
• Collaborate with Clinical Development on safety monitoring activities, Data Safety Monitoring Board (DSMB) materials, safety sections of clinical protocols, Investigator Brochures (IBs), and Clinical Study Reports (CSRs).
• Partner with Regulatory Affairs on safety labeling strategy, Core Data Sheet (CDS) maintenance, and preparation of written responses to Health Authority safety queries.
• Contribute to risk management activities, including Risk Management Plans (RMPs), REMS development, and risk minimization measure effectiveness assessments.
• Participate in safety governance bodies, including company safety review committees and cross-functional benefit-risk working groups.
• Monitor evolving pharmacovigilance regulations, ICH guidelines, and scientific literature relevant to drug safety in immunology, inflammation, and biologics development
• Perform other duties and responsibilities as assigned

Qualifications:

• Education: Advanced degree required; PharmD, or PhD in a biomedical or clinical discipline strongly preferred
• 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.
• Deep knowledge of global PV regulatory frameworks, including FDA 21 CFR, EU GVP Modules, ICH E2A–E2F guidelines, and MedDRA coding conventions.
• Demonstrated experience leading or contributing to signal detection programs, including use of pharmacovigilance databases, EBGM/PRR analyses, and systematic safety literature review.
• Experience authoring aggregate safety reports including DSURs, PSURs/PBRERs, and Integrated Summaries of Safety (ISS) for regulatory submissions.
• Strong medical case review skills with experience writing and reviewing complex individual case safety narratives, including medically significant and fatal events.
• Proven track record of influencing without authority across organizational boundaries, driving alignment among senior stakeholders, and building consensus on complex scientific or operational priorities.
• Experience navigating organizational ambiguity and change; capable of defining structure, establishing priorities, and scaling functional capabilities in alignment with evolving corporate strategy.
• Exceptional written and verbal communication skills with demonstrated ability to translate complex scientific, regulatory, or operational content for diverse audiences, including executive leadership, clinical teams, and external partners.
• Adept at facilitating productive dialogue in high-stakes meetings, negotiations, and multi-party collaborations; balances clarity, diplomacy, and scientific precision.
• This position may require domestic travel up to 10%+ of time or more including overnight stay driven by business need; position must be able to work eastern time zone.