Director of Pharmacovigilance

Director Pharmacovigilance

Greater Boston Area - Hybrid

Compensation: $200,000-264,000 + 20% bonus + Lucrative RSU package

Company Summary:

A mid-sized biotech company at the forefront of developing innovative therapeutic products for endocrine and orphan lung diseases is looking for a Pharmacovigilance Director. The already have two key products approved that generated over $200 million in revenue this past year and the have 2 phase 3 studies in development. One of their drugs in development has fast-track designation and given their previous track record of getting pulmonary products approved you can have additional confidence in the efficacy of their science. Their unique delivery method can be used with a variety of drugs, including small molecules and biologics, making it a versatile platform for different therapeutic applications for years to come. If interested in learning more don't hesitate to apply.

Primary Responsibilities:

• Support the planning and implementation of Phase 1-4 clinical studies, including drafting protocols, protocol amendments, safety sections of Investigator's Brochures (IBs), Informed Consent Forms (ICFs), and other safety-related documentation. Provide oversight for safety elements within operational strategies.
• Manage safety surveillance activities across the development pipeline, including adverse event reporting frameworks, signal identification, risk mitigation, and creation of Safety Monitoring Plans (SMPs) and Safety Review Committee (SRC) Charters. Supervise external safety service providers and related functions.
• Act as the primary safety contact across Clinical Development, Clinical Operations, Regulatory, Quality Assurance, Biostatistics, Medical Affairs, and external collaborators to ensure smooth study execution and uphold safety protocols.
• Collaborate with key opinion leaders (KOLs) and scientific advisory panels to guide protocol development, dose determination, and endpoint selection, integrating external expertise into clinical and safety strategies.
• Assist in the preparation and evaluation of global regulatory filings (e.g., INDs, CTAs, DSURs, REMS, BLAs/sBLAs, NDAs), including addressing safety-related inquiries from regulatory agencies. Contribute to safety narratives and strategic input for briefing materials and regulatory meetings.
• Lead or assist in continuous safety data assessments to identify trends or concerns. Partner with clinical scientists, study managers, data teams, and statisticians to interpret findings and compile interim and final study reports.
• Aid in the development of manuscripts, conference posters, and scientific presentations to disseminate clinical trial outcomes to the broader medical and scientific communities.
• Ensure adherence to Good Clinical Practice (GCP), International Council for Harmonization (ICH) guidelines, and global pharmacovigilance standards. Recommend and implement enhancements to streamline safety operations.

Ideal Qualifications:

• Advanced degree (PharmD, MD, or PhD)
• 8+ years of professional experience in the pharmaceutical or biotechnology sector, with a focus on clinical development, drug safety, or clinical research.
• Demonstrated involvement in both early-stage and late-stage clinical trials (Phases 1 through 4).
• Solid expertise in pharmacovigilance practices and safety oversight, including signal identification and preparation of aggregate reports.
• Proven ability to establish and manage pharmacovigilance systems within small to mid-sized biotech organizations.
• Familiarity with rare disease or metabolic/diabetes therapeutic areas is considered an asset.