Sr. Global Pharmacovigilance Business Partner Manager at Astellas Pharma Inc. — NeverHard

Position Summary This role is accountable for assisting in the development of strategies and implementation of program management activities for safety alliance operations with license partners. The incumbent is the main point of contact for Astellas business development and its affiliates, responsible for establishing and maintaining business relationships and ensuring compliance with Astellas Pharmacovigilance Agreements (PVAs) and worldwide regulatory requirements. The role leads the PVA function, contributes to the development and implementation of the PV mission, objectives, and 1‑3 year strategic plan, and may supervise direct reports as part of the BPM management team. Essential Job Duties Contribute to the strategy for PVAs and, as applicable, Intra‑company Agreement program management. Line or outsourced resource management of the PVA group. Build collaborative relationships with business development, alliance management and legal groups to enable timely identification of contracts requiring PVA development. Serve as the main point of contact for matters relating to PVAs, Intra‑company Agreements, and license partners. Lead the establishment of PVA processes and workflows that create efficiencies between partners, internal PV stakeholders, M&D and MA cross‑functional teams, business development, and legal groups. Manage communications and remediation actions between PV and license partners during alliance management. Serve as subject‑matter expert during audits or regulatory authority inspections, coordinate CAPA actions, and liaise with CRQA regarding audit strategy. Oversee and/or manage operations to keep all PVAs current and ensure timely re‑negotiations or terminations. Act as second line of escalation during PVA negotiations; may execute complex PVAs, mentor junior staff, and assist in QC of all agreements. Liaise with the QPPV office to provide information on PVA commitments, risks and metrics. Author or contribute to procedures for PVA development and maintenance, ensuring templates and procedures comply with regulations and Astellas policies. Monitor industry external environment and benchmark PV safety alliance processes against best practices; represent GPV on industry alliance or peer groups. Accountability Accountable for all PVAs; implementation, management and monitoring have a significant impact on compliance and partner relationships, with potential financial impact for non‑compliance. Project Activities Oversee multiple projects managed by others. Independently manage or lead complex projects. Lead cross‑functional teams to establish and implement PVA strategy. Quantitative Dimensions Line management of designated direct reports. Establish key performance indicators and metrics methodology to manage operations and improve quality and compliance. Manage and oversee approximately 100 PVAs. Primary point of contact for more than 50 business partners. Failure to meet contractual obligations can have financial consequences. Critical Interactions Frequent interactions with senior management from license partners, Astellas business development, legal, EU QPPV, CQA, affiliate DSOs, and affiliate general managers. Required Qualifications Minimum BA/BS degree. 7+ years’ experience in the pharmaceutical industry, with at least 6 years in Pharmacovigilance; preferably in the PVA space. 3+ years managing staff with proven ability to supervise and mentor. Significant working knowledge of pharmacovigilance regulations and guidelines, including ICH and EU regulations. Preferred Qualifications Advance degree (MBA/JD) preferred. Additional Information Astellas Pharma Canada welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates during all aspects of the hiring process. Astellas Pharma Canada requires full vaccination against COVID‑19 as a condition of employment; reasonable accommodation may be granted for a valid accommodation request under human rights legislation. #J-18808-Ljbffr