Global Pharmacovigilance Medical Director

Beeline Medicines

17h • $266,000 - $344,000 • Remote

About The Position

The Pharmacovigilance Medical Director is the senior medical authority within Beeline Medicines’ drug safety function, providing expert medical and scientific leadership across pharmacovigilance activities supporting the immunology and inflammation pipeline, including the lead lupus program. The role is the primary physician voice for benefit-risk evaluation, signal assessment, and safety governance, with patient safety as the foundational principle of clinical development and post-market activities. The Medical Director partners with the Head of Pharmacovigilance, Clinical Development, Regulatory Affairs, Medical Affairs, and external Health Authorities to provide medically sound, strategically aligned safety leadership.

This position is designated as remote, with periodic travel to Beeline Medicines’ offices for in-person collaboration, team engagement, and business operations. Visit frequency and scheduling are determined by the company based on business needs.

Requirements

• Medical degree (MD or DO).
• At least 5 years of combined clinical and pharmaceutical or biotechnology industry experience.
• Demonstrated expertise serving as a physician of record for pharmacovigilance programs, including ICSR medical review, signal evaluation, benefit-risk assessment, and aggregate safety reporting.
• Deep knowledge of global safety and pharmacovigilance regulations, including FDA guidance, EU GVP Modules I–XVI, and ICH guidelines.
• Extensive experience providing medical leadership for safety surveillance plans, benefit-risk assessments, and IND and NDA/BLA submissions, including authorship or oversight of complex safety narratives for regulatory submissions.
• Proven experience engaging with global Health Authorities on pharmacovigilance topics, including regulatory meeting preparation, written responses to safety queries, and inspection support.
• Demonstrated ability to lead or participate in sponsor-level DSMB oversight, clinical trial safety monitoring, and safety governance committee activities.
• Experience contributing to Risk Management Plans and REMS programs, including development of risk minimization measures and assessment of their effectiveness.
• Demonstrated ability to lead, mentor, and develop cross-functional teams in a fast-paced, resource-constrained biotechnology or pharmaceutical environment, while fostering accountability, inclusion, and continuous learning.
• Proven ability to influence without authority across organizational boundaries, align senior stakeholders, and build consensus on complex scientific or operational priorities.
• Exceptional written and verbal communication skills, including the ability to translate complex scientific, regulatory, or operational content for executive leadership, clinical teams, and external partners.
• Ability to prepare and deliver compelling presentations, briefing documents, regulatory responses, and strategic updates to cross-functional leadership teams and board-level stakeholders.

Nice To Haves

• Board certification or eligibility in immunology, rheumatology, internal medicine, or a relevant specialty; experience in autoimmune disease is strongly preferred.
• Two to three years of dedicated pharmacovigilance or drug safety experience is preferred.

Responsibilities

• Serve as the senior medical expert and physician for safety science and pharmacovigilance, providing medical judgment on individual case safety reports, aggregate safety analyses, signal evaluations, and benefit-risk assessments across the immunology and inflammation portfolio.
• Lead medical review and clinical interpretation of safety data from clinical trials, spontaneous reports, literature, and real-world sources, ensuring timely, accurate, and scientifically rigorous assessment.
• Direct development and ongoing maintenance of the benefit-risk framework and provide medical leadership for evaluations supporting regulatory submissions, label updates, and Health Authority safety communications.
• Lead discussions at the company’s safety surveillance governance forum, providing medical and strategic direction on signal management, escalation procedures, and corrective action planning.
• Oversee the medical content and scientific quality of aggregate safety reports and regulatory submission dossiers for safety content.
• Partner with Clinical Development on medical oversight of Data Safety Monitoring Board activities, clinical trial safety monitoring plans, safety risk mitigation plans, and protocol-level safety sections for active and planned studies.
• Provide expert medical input to Risk Management Plans and relevant regulatory documents throughout program development, and to the design, execution, and effectiveness assessment of risk minimization measures.
• Provide medical leadership and scientific mentorship to the Pharmacovigilance team, including PV Scientists, Medical Writers, and Operations personnel, fostering medical excellence and patient-first decision-making.
• Perform other duties and responsibilities as assigned.

Benefits

• Competitive health and wellness coverage, with structure and premiums varying by country.
• Paid time off, public holidays, and additional leave entitlements in accordance with local requirements.
• Flexible work arrangements or hybrid schedule.
• A discretionary annual bonus and long-term incentive award, such as equity, may be available based on individual and Company performance.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree