Associate Director, Pharmacovigilance Operations

TL;DR

Associate Director, Pharmacovigilance Operations (Biotech/Pharma): Day-to-day vendor oversight of post-marketing PV vendor ensuring high-quality and timely safety information with an accent on compliance, patient safety, and regulatory alignment. Focus on managing adverse event intake, reconciliations, training coordination, and stakeholder collaboration to support global PV strategy.

Location: Hybrid in Concord, MA - must be willing and able to come to office on a weekly basis

Salary: $185,000 - $220,000

Company

Fast-paced, growing biotech company developing therapeutics.

What you will do

• Perform day-to-day vendor oversight including adverse event intake, safety inbox management, performance monitoring, and training on ITF SOPs
• Ensure timely transmission of AE reports to global PV team and complete reconciliations with partners
• Respond to vendor questions on case management and collaborate on process improvements
• Lead PV awareness training for staff and vendors using LMS and live sessions
• Manage vendor relationships, contracts, and incorporate PV language with legal and commercial teams

Requirements

• 8-10+ years in pharmacovigilance or regulatory compliance in biotech/pharma
• Demonstrated experience managing PV vendors (4+ years)
• Strong FDA knowledge and experience with international PV regulations
• Bachelor’s degree in pharmacy, nursing, life sciences, or healthcare
• Ability to manage priorities in fast-paced environment focused on patient safety

Nice to have

• PharmD or advanced degree in nursing/pharmacy/healthcare
• Experience with EMA or MHRA
• Proven leadership in global matrixed environments
• Strategic communication for stakeholder alignment

Culture & Benefits

• Medical, Dental & Vision Insurance with nationwide flexible options
• 401k Company Match
• 100% Paid Bonding Leave
• Disability & Life Insurance
• Professional Development opportunities
• Flexible Time Off Package
• Additional well-being perks