Director, PV Alliance and Contract Management

🕒 vor 2 Monaten

🇺🇸 Vereinigte Staaten – Remote

💵 $185.100 - $245.100 / Jahr

⏰ Vollzeit

🔴 Experte

🛒 Einkauf

👻 Geisterscore 17%

Was es bedeutet: die Wahrscheinlichkeit, dass für diese Stelle niemand wirklich einstellt.So liest du es: 60 % oder höher heißt, wir halten das für einen Geisterjob. Niedrigere Werte sind weniger bedenklich.Wie wir werten: Dauer offen, Neuveröffentlichungen, offene Stellen vs Teamgröße, wie schnell Stellen geschlossen werden, und ob ein Gehalt angegeben ist.Hinweis: eine Schätzung aus öffentlichen Daten, kein Urteil über das Unternehmen. Echte Stellen können hoch punkten, nutze es also als Hinweis, nicht als Fakt.

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BeOne Medicines

WebsiteLinkedInAlle Stellen

10.000+ Mitarbeiter

Gegründet 2010

🧬 Biotechnologie

🏥 Gesundheitswesen

💊 Pharmazie

Biotechnology • Healthcare • Pharmaceuticals

BeOne Medicines ist ein globales Onkologieunternehmen mit Sitz in der Schweiz, das innovative Therapien entdeckt und entwickelt, die für Krebspatientinnen und -patienten weltweit erschwinglicher und besser zugänglich sind. Mit einem Portfolio, das Hämatologie und solide Tumoren abdeckt, beschleunigt BeOne die Entwicklung seiner vielfältigen Pipeline neuartiger Therapeutika durch interne Kompetenzen und Kooperationen. Mit einem globalen Team von mehr als 11.000 Mitarbeitenden auf sechs Kontinenten setzt sich das Unternehmen dafür ein, den Zugang zu Arzneimitteln für deutlich mehr Patientinnen und Patienten, die sie benötigen, grundlegend zu verbessern.

Beschreibung

• 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

🎯 Anforderungen

• 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%

🏖️ Vorteile

• 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

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