Director – PV Contracts and Agreements

This is a fully remote position, open to applicants in United States.

📋 Description

• Direct the global team of pharmacovigilance (PV) contract managers.

• Develop and oversee the strategy for PV contracts and agreements, ensuring compliance with contractual obligations.

• Provide oversight for PV contracts and agreements on behalf of the EU Qualified Person for Pharmacovigilance (QPPV).

• Offer guidance to the business regarding PV contract and agreement requirements while supporting business development initiatives.

• Create and implement efficient processes for the management and tracking of PV contracts and agreements, including Safety Data Exchange Agreements (SDEAs) and templates.

• Contribute to the creation and upkeep of a global Pharmacovigilance Agreement (PVA) template.

• Act as the primary contact for SDEAs/PVAs with both internal stakeholders and external business partners.

• Enhance organizational knowledge of PV contracts and agreements processes and systems.

• Supervise the contractual obligations and deliverables of SDEAs throughout the partnership lifecycle.

• Evaluate existing PV contracts and agreements, suggesting necessary revisions.

• Identify and address risks or disputes with business partners, escalating to senior leadership as required.

• Maintain legal protocols used in the execution of pharmacovigilance contracts.

• Ensure PV contract and agreement processes are aligned with global pharmacovigilance legislation.

• Assist business partners with due diligence activities.

• Organize and lead forums focused on best practices and knowledge sharing.

• Oversee the preparation, negotiation, and finalization of SDEAs/PVAs for both development and commercial partnerships.

• Collaborate with potential partners and the internal Legal team on agreements and contracts.

• Communicate contractual obligations to internal and external stakeholders, ensuring adherence to compliance standards.

• Partner with PV Compliance to address any PVA compliance matters.

• Drive the identification and resolution of issues related to PV alliances and partnerships.

• Assist affiliates and business partners in reviewing and executing pharmacovigilance contracts.

• Ensure the accuracy of PV agreement content within the Pharmacovigilance System Master File (PSMF).

• Guarantee compliance with company policies, legal and regulatory requirements, and industry standards.

• Participate in internal audits of pharmacovigilance contractual partners and aid in managing outcomes.

• Serve as a subject matter expert for GPS pharmacovigilance system audits and inspections.

• Manage the resources involved in negotiating and executing PV contracts and agreements.

⛳️ Requirements

• A bachelor’s degree in life sciences, pharmacy, nursing, or a related field.

• A minimum of 10 years of experience in managing pharmacovigilance contracts and agreements.

• Exceptional negotiation skills with a proven ability to identify mutual interests for successful agreements.

• Demonstrated experience in managing resources responsible for PV contracts and agreements.

• Thorough understanding of global pharmacovigilance agreement regulations and guidelines, including EU Good Pharmacovigilance Practices (GVP).

• Proven ability to support compliance within the pharmacovigilance domain.

• Experience in managing Individual Case Safety Reports (ICSRs) and Aggregate Reports.

• Strong interpersonal and presentation skills, with the ability to communicate effectively with senior leaders.

• Excellent oral and written communication skills.

• Capability to navigate ambiguity and make decisions in a fast-paced, evolving environment.

• Strong analytical and strategic thinking abilities with a keen attention to detail.

• Willingness to travel both internationally and domestically, approximately 20% of the time.

• An advanced degree (MS, Ph.D., Pharm D., etc.) is preferred.

🏝️ Benefits

• Eligibility for an annual bonus plan for non-commercial roles.

• Access to discretionary equity awards.

• Participation in the Employee Stock Purchase Plan.

• Comprehensive medical insurance.

• Dental insurance coverage.

• Vision insurance.

• 401(k) retirement plan.

• Flexible Spending Account (FSA) / Health Savings Account (HSA).

• Life insurance coverage.

• Paid Time Off (PTO).

• Wellness programs.