Vice President, Head of Pharmacovigilance Operations, Innovation & Analytics

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

• Lead all operational aspects of the Safety and Risk Management (SRM) Expertise Area, including Pharmacovigilance Reporting Compliance, safety information case management, and PV process innovation and implementation.
• 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.
• Collaborate with Alnylam Quality Assurance to ensure effective management and conduct of audits and inspections and promote a successful PV Quality Management System.
• Ensure all relevant SOPs and systems/processes are in place for an efficient and compliant Safety & Risk Management organization.
• Provide strategic consultation and guidance to all EAs in development and commercial/Medical Affairs on decisions with significant pharmacovigilance operative implications.
• Oversee tracking of KPIs for reporting of compliance metrics related to SRM and Regulatory Quality activities.
• Provide strategic leadership and input into system requirements and process design for pharmacovigilance operations and analytics, including Argus, PVReports, and Empirica.
• In partnership with the QPPV, provide strategic direction and quality and compliance leadership to SRM.
• Define and execute PV vendor strategy, ensuring strong governance, clear accountability, and high-performing partnerships.
• Provide strategic leadership and performance management of external partners, including Case Management / Medical Review vendors and clinical trial safety reporting vendors.
• 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.
• Serve as a key strategic advisor to senior leaders on operating model design, systems strategy, and execution effectiveness.
• Champion a culture of collaboration, transparency, accountability, and innovation.
• Develop organizational capabilities that enable the company to scale and deliver across development and commercial pharmacovigilance activities.

Qualifications

• Bachelor's degree in a scientific, healthcare field, with a minimum of 20 years of relevant work experience in a pharmacovigilance or related operational Biotech/Pharma global role.
• MD degree or other senior degree highly preferred.
• Must have progressive experience serving in a management role with remit including pharmacovigilance, risk management, and quality-related matters.
• Experience in leading compliance or audits with working knowledge of relevant FDA, EU, ICH guidelines, Good Pharmacovigilance Practice (GVP) regulations, governing both Safety reporting and processing for clinical trial environments, and regulatory quality aspects.
• Proven ability to design and operationalize governance models, decision-making frameworks, escalation pathways, and pharmacovigilance compliance and performance management processes.
• Demonstrated success in organizational transformation and operating model design and implementation.
• Significant experience managing strategic partnerships, CROs, and external service providers, including vendor governance, performance management, and contract oversight.
• Strong financial and business acumen, including experience partnering with Finance on forecasting, budgeting, investment planning, and scenario modeling.
• Experience developing executive-level insights, dashboards, and performance metrics to support informed decision-making and organizational transparency.
• Exceptional leadership, collaboration, and influencing skills with demonstrated success working across highly matrixed organizations and senior leadership teams.
• Strong strategic thinking and problem-solving capabilities with the ability to anticipate risks, evaluate trade-offs, and drive operational excellence.
• Excellent communication and executive presence with the ability to synthesize complex information into clear, actionable recommendations.
• Demonstrated ability to lead organizational change, build scalable operating models, and drive continuous improvement initiatives.
• Demonstrate and lead with clear alignment to Alnylam Core Values including Commitment to People, Innovation and Discovery, Sense of Urgency, Open Culture and Passion for Excellence.