Director, PV Alliance and Contract Management

BeiGene

7d•$185,100 - $245,100

About The Position

The Director, PV Alliance and Contract Management leads the global team of PV Alliance and Contract Management and is responsible for ensuring that the global strategic approach as well as the day-to-day operating requirements for pharmacovigilance partners is effectively managed and objectives achieved in order to maximize the strategic value of BeOne’s PV partnerships. This position contributes to the establishment of tools, processes, and strategies employed by Global Patient Safety to ensure effective coordination between business partners as well as to proactively manage compliance risks.

Requirements

Bachelor’s degree in life sciences, pharmacy, nursing or equivalent with minimum 10+ years of related experience.
Minimum of 8–10 years of experience working with pharmacovigilance contracts and /or Alliance Management.
Deep understanding of complex partnerships including licensing, co-development and Clinical Services.
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/or Alliance Management.
Expert command of global pharmacovigilance agreement regulations and guidelines, including but not limited to EU Good Pharmacovigilance Practices (GVP), GCP and CDx.
Proven track record of supporting compliance within the PV space.
Knowledge of Individual Case Safety Reports (ICSRs) and Aggregate Safety 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.
Strong experience with MS Office Suite, project management and collaboration tools such as Smartsheet.
Strong familiarity with lifecycle contract management tools.
Ability to learn and apply new application skills, particularly using AI/automation.

Responsibilities

Provides expertise, leadership, and direction in business partnerships as they relate to development, commercialization, medicinal and devices.
Stays abreast of all business development and commercial activities across BeOne to ensure pharmacovigilance and contractual obligations are met.
Oversee PV due diligence and Business Development activities (as requested) and ensure and oversee subsequent implementation actions
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.
Works closely with GPS leadership to establish the strategy for the PV partners across disciplines, aligning across pillars and supporting implementation of PV requirements.
Delivers high-quality and timely input in support of GPS department business plans and priorities
Oversee and ensures effective management of business partner relationships to ensure collaboration and compliance with PV/CDx and other requirements.
Ensures the maintenance of robust infrastructure to disseminate key information regarding responsibilities and obligations from the PVAs and other contracts to relevant staff, including the use of PVA management tools & systems/applications
Foster productive working relationships with all stakeholders.
Acts as a key contact point on all matters relating to business partnerships with internal stakeholders (e.g., Safety, Quality, Regulatory, Business Development, Alliance Managers, Supply, Commercial, Legal, Affiliates) and external business partners.
Provides oversight on matters related to PV contracts and agreements on behalf of the EU QPPV.
Ensures and oversees the infrastructure for disseminating key information regarding responsibilities and obligations from the PVAs to relevant staff, including the use of PVA management tools & systems/applications
Ensures oversight of all contractual obligations and associated deliverables throughout the lifecycle of business partnerships.
Ensures awareness of and compliance with PVAs and PV Clauses and obligations by accountable functions
Proactively identifies risks or points of disagreement with business partners and addresses issues in a time-sensitive manner, engaging GPS leadership as required.
Provide leadership and guidance in the identification and resolution of issues with PV alliances/partnerships.
Leads contributions to the maintenance of legal procedures used in the execution of pharmacovigilance contracts.
Leads PV contract and agreement process by managing and tracking PV contracts and agreements including PVA, PV Clauses and associated templates
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, Licensing, Clinical Service Agreements, Clinical Supply 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.
Collaborate with the PV Compliance group to address and resolve compliance issues associated with PVAs.
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.
Supervising personnel involved in the negotiation and execution of PV Alliance contracts and agreements.