Global Pharmacovigilance Director

Treeline; Watertown (MA); On-site; USD 230,000 - 295,000; Full time

Job summary

Treeline Biosciences in Watertown, MA, seeks a Director of Pharmacovigilance to provide strategic and operational leadership for global drug safety, overseeing safety operations, signal detection, and regulatory reporting from early development through commercialization.

The role collaborates with Clinical Development, Regulatory Affairs, Data Management, and Quality Assurance to maintain a high-quality PV program, prepare DSURs and annual safety reports, and support regulatory submissions while

Qualifications

• 8+ years in pharmacovigilance within biotech/pharma/CRO settings.
• Experience supporting global clinical development programs.
• Experience managing outsourced pharmacovigilance vendors.

Responsibilities

• Oversee day-to-day pharmacovigilance activities with internal and external vendors.
• Lead preparation of DSURs, annual safety reports, and safety sections of regulatory documents.
• Collaborate cross-functionally to ensure safety oversight and regulatory compliance.

Skills

Pharmacovigilance leadership

Drug safety oversight

Regulatory submissions

Education

MD/NP/PharmD/PhD or equivalent life sciences degree

Bachelor's or Master's in a relevant scientific discipline

Job description

Treeline Biosciences in Watertown, MA, seeks a Director of Pharmacovigilance to provide strategic and operational leadership for global drug safety, overseeing safety operations, signal detection, and regulatory reporting from early development through commercialization.

The role collaborates with Clinical Development, Regulatory Affairs, Data Management, and Quality Assurance to maintain a high-quality PV program, prepare DSURs and annual safety reports, and support regulatory submissions while