Director, PV Alliance and Contract Management

🕒 Agosto 25

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $185.100 - $245.100 / ano

⏰ Tempo Integral

🔴 Especialista

🛒 Suprimentos (Compras)

👻 Score fantasma 11%

O que significa: quão provável esta vaga está aberta sem contratação ativa.Como ler: 60% ou mais significa que achamos que é uma vaga fantasma. Pontuações mais baixas preocupam menos.Como pontuamos: tempo em aberto, republicações, vagas abertas vs tamanho do time, rapidez para fechar vagas, e se o salário está divulgado.Observação: é uma estimativa de dados públicos, não um julgamento da empresa. Vagas reais podem ter pontuação alta, então use como uma dica, não como um fato.

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BeOne Medicines

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 2010

🧬 Biotecnologia

🏥 Saúde

💊 Farmacêutico

Biotechnology • Healthcare • Pharmaceuticals

A BeOne Medicines é uma empresa global de oncologia, com sede na Suíça, que descobre e desenvolve tratamentos inovadores mais acessíveis e com maior disponibilidade para pacientes com câncer em todo o mundo. Com um portfólio que abrange hematologia e tumores sólidos, a BeOne está acelerando o desenvolvimento de seu diversificado pipeline de novas terapias por meio de capacidades internas e colaborações. Com uma equipe global em crescimento, formada por mais de 11.000 colaboradores presentes em seis continentes, a empresa está comprometida em melhorar radicalmente o acesso a medicamentos para muito mais pacientes que deles precisam.

Descrição

• Lead the global team of PV Alliance and Contract Management • Ensure the global strategic approach and day-to-day operating requirements for pharmacovigilance partners are effectively managed • Maximize the strategic value of BeOne’s PV partnerships • Contribute to tools, processes and strategies for Global Patient Safety • Provide expertise, leadership and direction for business partnerships involving development, commercialization, medicinal products and devices • Monitor business development and commercial activities to ensure pharmacovigilance and contractual obligations are met • Oversee PV due diligence and business development activities and subsequent implementation actions • Advise the business on PV contracts and agreement requirements and support business development planning • Establish strategy for PV partners across disciplines and support implementation of PV requirements • Manage business partner relationships to ensure collaboration and compliance with PV/CDx and other requirements • Maintain infrastructure and tools for disseminating PVA and contract responsibilities and obligations • Serve as a key contact for internal stakeholders and external business partners • Provide oversight of PV contracts and agreements on behalf of the EU QPPV • Oversee contractual obligations and deliverables throughout business partnership lifecycles • Identify and resolve risks, disagreements and compliance issues with business partners • Lead maintenance of legal procedures for executing pharmacovigilance contracts • Manage and track PV contracts and agreements, including PVAs, PV Clauses and templates • Plan and conduct best-practice and knowledge-sharing forums • Lead preparation, negotiation and conclusion of SDEAs/PVAs for development, licensing, clinical service, clinical supply and commercial partnerships • Work with potential partners and internal Legal on agreements and contracts • Support affiliates and business partners in reviewing and executing pharmacovigilance contracts • Maintain the integrity of PV agreement content in the Pharmacovigilance System Master File (PSMF) • Contribute to internal audits of pharmacovigilance contractual partners and manage outcomes • Serve as subject matter expert for audits and inspections of the GPS pharmacovigilance system • Supervise personnel involved in negotiating and executing PV Alliance contracts and agreements

🎯 Requisitos

• 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 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 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 • Willingness to travel internationally and domestically 20%

🏖️ Benefícios

• 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 benefits • Equal opportunity employer • Reasonable accommodation during the job application process