Manager, Pharmacovigilance Agreements (Drug Safety)

TL;DR

Manager, Pharmacovigilance Agreements (Drug Safety): Lead end-to-end development, negotiation, implementation, and lifecycle management of Safety Data Exchange Agreements (SDEAs), Pharmacovigilance Agreements (PVAs), and Pharmacovigilance Clauses (PVCs) with external partners with an accent on global regulatory compliance and alignment with internal policies. Focus on evaluating obligations, assessing compliance risks, driving process improvements, and cross-functional collaboration for patient safety and inspection readiness.

Location: Fully remote from anywhere (occasional travel ~20% expected)

Salary: $133,000–$173,000 Annual

Company

Global biopharmaceutical company dedicated to transforming lives of patients with serious and rare diseases.

What you will do

• Lead development, negotiation, implementation, and maintenance of SDEAs, PVAs, and PVCs with CROs, MAHs, distributors, and vendors
• Ensure timely execution aligned with global PV requirements (ICH E2D, EU GVP, FDA 21 CFR 314) and company procedures
• Maintain tracking, documentation, version control, renewals, and reviews of all PV agreements
• Evaluate PV obligations, identify and escalate compliance risks or deviations
• Monitor KPIs for agreement performance, drive process improvements for efficiency and data quality
• Manage agreements in SharePoint, update PSMF contractual provisions, and collaborate cross-functionally to resolve issues

Requirements

• Bachelor’s Degree in life sciences or clinical research, or licensed healthcare professional
• 5+ years relevant industry experience including 3+ years in drug safety
• In-depth knowledge of medical terminology, GCP, ICH guidelines, global PV regulations (US and international)
• Strong interpersonal, communication, and partner relationship management skills
• Proficiency in MS Office (Outlook, Word, Excel, PowerPoint); experience with SharePoint
• Ability to manage priorities independently, exercise judgment, and build collaborative relationships

Culture & Benefits

• Comprehensive medical, dental, vision coverage, mental health support, wellbeing reimbursement, EAP
• Generous PTO, fertility/family benefits, caregiver support, flexible schedules
• 401(k) with company match, equity awards, ESPP, company-paid life/disability insurance
• Learning Institute with LinkedIn Learning, workshops, leadership programs, mentorship
• Employee resource groups, recognition programs, volunteering opportunities