Vice President, Head of Pharmacovigilance Operations, Innovation & Analytics

Job description

Overview The Vice President, Head of Pharmacovigilance Operations, Innovation & Analytics SRM is a critical executive-level role responsible for defining, governing, and scaling the operating model that enables Alnylam’s Safety & Risk Management (SRM), Regulatory Sciences organization to execute on pharmacovigilance with speed, quality, and predictability across a growing and increasingly complex portfolio, both in Clinical Development and on the Market. This leader owns the integrated planning architecture, governance frameworks, resource and capacity strategy, external partner performance and delivery performance insights, including managing a large budget that enable Safety & Risk Management to execute on Alnylam pharmacovigilance regulatory duties across the world.  This is a high-impact, high-visibility position at a pivotal moment: Alnylam is growing and the SRM, Regulatory Sciences organization must scale rapidly. The position will report directly to the Senior Vice President of Global Patient Safety & Risk Management. The VP will serve as a key strategic advisor to Regulatory Sciences, SRM leadership while building and leading a high-performing Pharmacovigilance Operations, Innovation & Analytics team that will accelerate the organization’s ability to safely deliver medicines to patients, both in development and market. This position is hybrid-based and candidates must be willing to travel into our US offices either in Cambridge, MA or Philadelphia, PA. Key Responsibilities The VP Head of Pharmacovigilance Operations, Innovation & Analytics is responsible for leading all operational aspects of the Safety and Risk Management (SRM) Expertise Area. Key accountability includes Alnylam Pharmaceuticals Pharmacovigilance Reporting Compliance, safety information case management, a foundational role to scientific knowledge building for all Alnylam development and commercial products, Pharmacovigilance processes innovation and implementation, including business partners vendor management. • Build and lead high-performing Pharmacovigilance Operations, Innovation & Analytics teams, providing strategic oversight and financial soundness. • Provide strategic leadership and oversight of process design, evaluation and review of all SRM procedures, PV operational innovation and excellence; • Foster strong partnerships with Commercial and Medical Affairs, Clinical Operations, Quality Assurance, Data Management, IT, Finance, and external partners. • Collaborates and partners with Alnylam Quality Assurance department to ensure the effective management and conduct of audits and inspections and to promote a successful PV Quality Management System • Ensures all relevant SOPs and systems/ processes are in place making for an efficient and compliant Safety & Risk management organization • Provides strategic consultation and guidance to all EAs in development and commercial/Medical Affairs on all decisions that have significant pharmacovigilance operative implications, including safety reporting operational aspects of postmarketing studies, market research activities, Patient Access programs (ie Alnylam Assist); • Oversees tracking of KPIs for reporting of compliance metrics related to SRM and Regulatory Quality activities; • Provides strategic leadership and input into the system requirements and process design for pharmacovigilance operations and analytics, collaborating with IT in ensuring efficient and high quality PV systems are in effect, including Argus, PVReports, & Empirica and any other IT systems; • In partnership with the QPPV, provides strategic direction and quality and compliance leadership to SRM; • Define and execute PV vendor strategy, ensuring strong governance, clear accountability, and high-performing partnerships that enable speed, quality, and cost efficiency while keeping an enterprise lens. • Provide strategic leadership and performance management of external partners — including Case Management / Medical Review vendors, clinical trial safety reporting vendors across all trials; • Drive vendor strategy, governance frameworks, and accountability mechanisms to ensure high-quality, cost-effective delivery. Ensure partner performance is aligned to safety reporting regulations and obligation timelines and organizational priorities. • Lead governance of Case Management / Medical Review and other partner relationships with a focus on value realization and risk mitigation.</li