Director, Pharmacovigilance
Treeline BiosciencesPrecision Medicine company
Watertown, United States$229,607 to $295,176Director
GV
KKR
T. Rowe Price
AI Life Sciences
ARCH Venture Partners
OrbiMed
Legal & Compliance
About the role
TL;DR
Director of Pharmacovigilance to oversee global safety activities and ensure regulatory compliance.
- •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.
- •Key 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.
- •Contribute to ongoing safety surveillance and signal detection activities.
- •Lead preparation and review of aggregate safety reports, including DSURs and annual safety reports.
- •Develop and maintain pharmacovigilance SOPs, work instructions, and quality documentation.
- •Requirements MD, NP, PharmD, PhD, or equivalent advanced life sciences degree preferred. 8+ years of pharmacovigilance experience within biotechnology, pharmaceutical, or CRO settings.
- •Strong understanding of global pharmacovigilance regulations, including FDA, EMA, PMDA and ICH.
- •Experience preparing aggregate safety reports and supporting regulatory submissions.
- •Excellent clinical judgment and risk assessment skills.
Required skills
PythonSQLGitLinuxJiraConfluenceExcelPowerPoint
Domain expertise
biotechhealthcare
Tech stack
PythonJavaScriptSQLBashGitLinuxJiraConfluencePostmanSwaggerREST APIExcelPowerPoint