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Director – PV Contracts and Agreements
BeOne MedicinesDirector leading pharmacovigilance contracts and agreements for BeOne, a medicines company. Managing global PV teams, SDEAs/PVAs, compliance, negotiations, and alliance partnerships.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing pharmacovigilance contracts and agreements, ensuring compliance with global regulations and guidelines. Proven ability to lead negotiations, develop scalable processes, and maintain strong relationships with internal and external stakeholders.
Highest-signal resume keywords
Pharmacovigilance Contracts ManagementExpert Negotiation SkillsGlobal Pharmacovigilance RegulationsIndividual Case Safety Reports (ICSRs)Compliance Support
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Pharmacovigilance AgreementsSDEAs/PVAs PreparationContractual Obligations ManagementRisk Identification and ResolutionProcess Development and ImplementationLegal Procedures in PharmacovigilanceAudit SupportAggregate Reports ManagementAttention to DetailStrategic Thinking
Soft Skills
Interpersonal SkillsPresentation SkillsCommunication SkillsDecision-MakingAbility to Deal with Ambiguity
Tools & Technologies
GPS Pharmacovigilance System
Industry Keywords
EU Good Pharmacovigilance Practices (GVP)Pharmacovigilance ComplianceBusiness Development PlanningStakeholder EngagementDue Diligence Activities
About the role
Key responsibilities & impact- Lead the global team of PV contract managers
- Lead PV contracts and agreements strategy and ensure contractual obligations are met
- Provide oversight on PV contracts and agreements on behalf of the EU QPPV
- Advise the business on PV contracts and agreements requirements and support business development planning
- Develop and implement scalable processes for managing and tracking PV contracts and agreements, including SDEAs and templates
- Contribute to development and maintenance of a global PVA template
- Serve as key contact for SDEAs/PVAs with internal stakeholders and external business partners
- Build enterprise knowledge of PV contracts and agreements processes and systems
- Oversee SDEA contractual obligations and deliverables throughout business partnership lifecycles
- Review existing PV contracts and agreements and initiate revisions
- Identify and resolve risks or disagreements with business partners, engaging senior leadership as needed
- Maintain legal procedures used in pharmacovigilance contract execution
- Ensure alignment of PV contract and agreement processes with global PV legislation
- Support business partner due diligence activities
- Plan and conduct best-practice and knowledge-sharing forums
- Lead preparation, negotiation, and conclusion of SDEAs/PVAs for development and commercial partnerships
- Work with potential partners and internal Legal on agreements and contracts
- Communicate contractual obligations internally and externally and ensure compliance
- Collaborate with PV Compliance to resolve PVA compliance issues
- Lead identification and resolution of PV alliance/partnership issues
- Support affiliates and business partners in reviewing and executing pharmacovigilance contracts
- Ensure integrity of PV agreement content in the PSMF
- Ensure compliance with company guidelines, legal and regulatory requirements, and industry practice
- Contribute to internal audits of pharmacovigilance contractual partners and support outcome management
- Serve as subject matter expert for GPS pharmacovigilance system audits and inspections
- Manage resources involved in negotiation and execution of PV contracts and agreements
Requirements
What you’ll need- Bachelor’s degree in life sciences, pharmacy, nursing or equivalent
- 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 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 ability to liaise with senior leaders
- Excellent oral and written communications
- Ability to deal with ambiguity and make decisions in a high-growth, rapidly evolving environment
- Strong analytical and strategic thinking skills with attention to detail
- Ability to travel internationally and domestically, 20%
- Advanced degree (MS, Ph.D., Pharm D., etc.) preferred
Benefits
Comp & perks- Annual bonus plan eligibility for non-commercial roles
- Discretionary equity awards
- Employee Stock Purchase Plan
- Medical insurance
- Dental insurance
- Vision insurance
- 401(k)
- FSA/HSA
- Life Insurance
- Paid Time Off
- Wellness