The Director, PV Contracts & Agreements leads the global team of PV contract managers and is responsible for ensuring that the global strategic approach, as well as the day-to-day operating requirements for pharmacovigilance contracts and agreements, is effectively managed and objectives achieved in order to maximize the strategic value of the company's alliance partnerships. This position contributes to the establishment of tools, processes, and strategies employed by Global Safety Operations and Innovation to ensure effective coordination between business partners and to proactively manage compliance risks.
Essential Functions of the Job:- Leads PV contracts and agreements strategy, staying abreast of business development and commercial activities to ensure contractual obligations are met.
- Provides oversight on matters related to PV contracts and agreements on behalf of the EU QPPV.
- Represents GPS as a key advisor to the business on PV contracts and agreements requirements and participates in planning activities to support and facilitate business development.
- Leads the development and implementation of a scalable process for managing and tracking PV contracts and agreements, including Safety Data Exchange Agreements (SDEAs) and associated templates.
- Partners with key stakeholders to contribute to the development and maintenance of a global PVA template.
- Acts as a key contact point on all matters relating to SDEAs/PVAs with internal stakeholders (e.g., Safety, Quality, Regulatory, Business Development, Alliance Managers, Supply, Commercial, Legal, Affiliates) and external business partners.
- Builds enterprise knowledge around GPS PV contracts and agreements processes and systems used to create and execute agreements.
- Ensures oversight of all SDEA contractual obligations and associated deliverables throughout the lifecycle of business partnerships.
- Oversees periodic reviews of existing PV contracts and agreements and initiates revisions where appropriate.
- Proactively identifies risks or points of disagreement with business partners and addresses issues in a time-sensitive manner, engaging senior leadership as required.
- Leads contributions to the maintenance of legal procedures used in the execution of pharmacovigilance contracts.
- Ensures ongoing alignment of PV contract and agreement processes with global PV legislation.
- Supports Business Partner due diligence activities on behalf of GPS, as required.
- Plans and conducts best-practice and knowledge-sharing forums with internal stakeholders and external advisory groups.
- Leads the preparation, negotiation and conclusion of SDEAs/PVAs relating to Development and Commercial partnerships.
- Works with potential partners and the internal Legal team on agreements and contracts.
- Ensures compliance with contractual obligations by effectively understanding and communicating such obligations internally and externally.
- Collaborates with the PV Compliance group to address and resolve compliance issues associated with PVAs.
- Provides leadership and guidance in the identification and resolution of issues with PV alliances/partnerships.
- Provides support to local and regional affiliates and business partners in the review and execution of pharmacovigilance contracts.
- Accountable for the integrity of all PV agreement content incorporated into the Pharmacovigilance System Master File (PSMF).
- Ensures compliance with company guidelines, legal and regulatory requirements, and industry practice.
- Contributes to the preparation and execution of internal audits of pharmacovigilance contractual partners and supports management of outcomes.
- Serves as subject matter expert for audits and inspections of the GPS pharmacovigilance system.
Supervisory Responsibilities:- Accountable for resources involved in the negotiation and execution of PV contracts and agreements.
Computer Skills: - Not specified in the source job description.
Education Required:- Bachelor's degree in life sciences, pharmacy, nursing or equivalent. Advanced degree (MS, Ph.D., Pharm D., etc., preferred.
Other Qualifications:- 10 years of experience working with pharmacovigilance contracts and agreements.
- Expert negotiation skills and demonstrated ability to identify areas of mutual interest required to achieve agreement.
- Demonstrated experience managing resources responsible for PV contracts and agreements.
- Expert command of global pharmacovigilance agreement regulations and guidelines, including but not limited to EU Good Pharmacovigilance Practices (GVP).
- Proven track record of supporting compliance within the PV space.
- Experience managing Individual Case Safety Reports (ICSRs) and Aggregate Reports.
- Strong interpersonal and presentation skills, including the ability to liaise with senior leaders.
- Excellent oral and written communications.
- Ability to deal with ambiguity and make decisions within a high-growth, rapidly evolving environment.
- Strong analytical and strategic thinking skills with attention to detail.
- Travel: International and domestic, 20%.
Salary Range: $185,100.00 - $245,100.00 annually
BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
