Director, PV Contracts and Agreements

About the role

For our client, we are seeking a Director, PV Contracts and Agreements to join the team of a leader in the Pharmaceuticals & Biotech space. This role will lead the strategy and oversight of pharmacovigilance contracts and agreements, ensuring they support business objectives while meeting global compliance expectations. The position will work closely with the EU QPPV, internal stakeholders, and external partners to strengthen safety data exchange practices and reduce compliance risk. It is well suited for a seasoned pharmacovigilance professional who can build scalable processes, drive periodic contract reviews, and foster best-practice collaboration across the organization.

Responsibilities

• Lead the strategy and oversight of pharmacovigilance contracts and agreements aligned with business objectives
• Oversee pharmacovigilance contracts on behalf of the EU QPPV and ensure compliance
• Develop and implement scalable processes for managing Safety Data Exchange Agreements (SDEAs)
• Serve as the primary contact for SDEAs with internal and external stakeholders
• Identify and address compliance risks with business partners promptly
• Conduct periodic reviews and initiate revisions of pharmacovigilance contracts as needed
• Facilitate best-practice forums for knowledge sharing among stakeholders

Qualifications

• Bachelor's degree in life sciences, pharmacy, nursing, or equivalent; advanced degree preferred
• 10+ years of experience in pharmacovigilance contracts and agreements
• Strong negotiation capabilities with a focus on mutual interests for agreements
• Strong command of global pharmacovigilance regulations, especially EU GVP guidelines
• Proven track record in ensuring compliance within pharmacovigilance practices
• Experience managing Individual Case Safety Reports (ICSRs) and Aggregate Reports
• Excellent interpersonal, oral, and written communication skills

Benefits

• Comprehensive benefits package including Medical, Dental, Vision, 401(k), FSA/HSA, and Life Insurance
• Paid time off and wellness programs supporting employee health
• Discretionary equity awards and optional participation in an Employee Stock Purchase Plan
• Opportunity for annual bonus for Non-Commercial roles and incentive compensation for Commercial roles