Director, Pharmacovigilance Treeline Biosciences Watertown, MA Job Details $229,607 - $295,176 a year 6 hours ago Qualifications Optimizing workflow processes FDA submissions Biotechnology Supplier performance analysis Doctor of Medicine Medicine Performance improvement leadership Clinical study protocols and reports Operations management Pharmacovigilance research Informed consent Procedural guides Adverse event reporting Clinical trial risk management Clinical incident reports Team leadership Safety regulations Metrics Reporting Investigational new drug (IND) applications Data summary reports 8 years ICH guidelines Doctor of Pharmacy Bachelor's degree Quality control documentation Doctor of Philosophy Pharmaceutical company experience Clinical data report preparation Vendor performance improvement Vendor relationship management

Full Job Description Director of Pharmacovigilance Position Summary:

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.

Key Responsibilities:

Safety Operations 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). Signal Detection & Risk Management 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. Medical Review & Regulatory Support 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. Cross-Functional Collaboration 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. Quality & Compliance 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.

Qualifications:

Education MD, NP, PharmD, PhD, or equivalent advanced life sciences degree preferred. Bachelor's or Master's degree in a relevant scientific discipline will be considered with significant pharmacovigilance leadership experience. Experience 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. Prior experience participating in inspections or audits preferred. Experience in oncology, immunology, neuroscience, or biologics is desirable. Knowledge, Skills & Competencies 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. This position is classified as exempt. The anticipated annual base salary range for candidates who will work in Watertown is $229,607 to $295,176. The final base salary offered to the successful candidate will be dependent upon several factors that may include but are not limited to the type and length of experience within the job, and other factors. Treeline Biosciences is a multi-state employer, and this salary range may not reflect positions that work in other cities or states. Recruitment fraud statement Please be aware of recruitment fraud and related job scams, where scammers present themselves as recruiters but are seeking to steal money or personal information. Keep the following in mind to protect yourself: Treeline Biosciences will never ask for money from you as part of our recruitment process. Do not provide bank details or pay somebody for the promise of a job at Treeline. We do not conduct interviews through RingCentral, Skype or Telegram. Our job openings are first posted to treeline.bio/careers. If you locate a listing for a Treeline job on another site, please ensure it is also posted on our careers website. You can find more information about job scams at consumer.ftc.gov/articles/job-scams. To report job scams, head to ReportFraud.ftc.gov. Notice to Search Firms/Third-Party Recruitment Agencies (Recruiters) The Human Resources team manages the recruitment and employment process for Treeline Biosciences. To protect the interests of all parties involved, Treeline Biosciences will only accept resumes from a recruiter if an executed search agreement directed to the particular position or positions is in place at the start of the recruitment effort. Unsolicited resumes sent to Treeline Biosciences from recruiters do not constitute any type of relationship between the recruiter and Treeline Biosciences and do not obligate Treeline Biosciences in any way to pay fees should we hire from those resumes. Recruiters are requested not to contact or present candidates directly to our hiring manager or employees.