Director – PV Contracts and Agreements

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🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $185.1k - $245.1k / year

⏰ Full Time

🔴 Lead

👔 Director

👻 Ghost score 1%

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BeOne Medicines

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2010

🧬 Biotechnology

🏥 Healthcare

💊 Pharmaceuticals

Biotechnology • Healthcare • Pharmaceuticals

BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting the development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them.

📋 Description

• 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

• 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

• 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