Director, Pharmacovigilance

Treeline Biosciences•Watertown, MA

About The Position

The Director of Pharmacovigilance (PV) will provide strategic and operational support for the Company’s global pharmacovigilance and drug safety activities. This individual will contribute to the timely detection, evaluation, reporting, and communication of safety information in compliance with global regulatory requirements while supporting the development of innovative therapies from early clinical development through commercialization planning. In this highly collaborative role, the Director will work closely with the VP Clinical Safety, Clinical Development, Clinical Operations, Medical Monitoring, Regulatory Affairs, Data Management, Biostatistics, Quality Assurance, and external pharmacovigilance vendors to maintain a high-quality safety program that supports patient safety and regulatory compliance.

Requirements

8+ years of pharmacovigilance experience within biotechnology, pharmaceutical, or CRO settings.
Demonstrated support of global clinical development programs.
Experience managing outsourced pharmacovigilance vendors.
Strong understanding of global pharmacovigilance regulations, including FDA, EMA, PMDA and ICH.
Experience preparing aggregate safety reports and supporting regulatory submissions.
Deep understanding of pharmacovigilance regulations, safety reporting, and signal detection.
Excellent clinical judgment and risk assessment skills.
Strong project management and organizational abilities.
Ability to influence cross-functional teams in a collaborative environment.
Excellent written and verbal communication skills.
Comfortable working in a fast-paced, evolving biotech environment.
Demonstrated ability to balance strategic leadership with operational execution.

Nice To Haves

MD, NP, PharmD, PhD, or equivalent advanced life sciences degree preferred.
Prior experience participating in inspections or audits preferred.
Experience in oncology, immunology, neuroscience, or biologics is desirable.

Responsibilities

Oversee day-to-day pharmacovigilance activities performed internally and by external safety vendors.
Ensure timely review, assessment, processing, tracking, medical evaluation, and regulatory reporting of adverse events, serious adverse events, SUSARs, and other safety information.
Monitor vendor performance through KPIs, quality metrics, and governance meetings.
Ensure inspection readiness and compliance with global pharmacovigilance regulations and Good Pharmacovigilance Practices (GVP).
Contribute to ongoing safety surveillance and signal detection activities.
Participate in benefit-risk assessments throughout clinical development.
Participate in establishing risk management strategies and safety governance.
Present emerging safety issues and recommendations at cross-functional team meetings.
Collaborate with Clinical Development and Medical Monitors on medical review of safety events.
Lead preparation and review of aggregate safety reports, including: Development Safety Update Reports (DSURs), Annual safety reports, Safety sections of Investigator’s Brochures, Clinical Study Reports, Regulatory responses related to safety.
Support preparation of INDs, CTAs, BLAs/NDAs, RFIs and other regulatory submissions.
Partner closely with Clinical Development, Clinical Operations, Regulatory Affairs, Biometrics, Quality Assurance, and CMC teams to ensure appropriate safety oversight.
Support Data Monitoring Committees and Safety Review Committees as needed.
Contribute to protocol development, informed consent documents, and safety monitoring plans.
Develop and maintain pharmacovigilance SOPs, work instructions, and quality documentation.
Support audits and regulatory inspections.
Drive continuous process improvement across pharmacovigilance activities.
Ensure compliance with FDA, EMA, TGA, PMDA, ICH, and other applicable global regulations.