Vice President, Head of Pharmacovigilance Operations, Innovation & Analytics

Alnylam Pharmaceuticals•Cambridge, MA

14h•$289,000 - $391,000•Hybrid

About The Position

The Vice President, Head of Pharmacovigilance Operations, Innovation & Analytics is an executive-level leader responsible for defining, governing, and scaling the operating model for Alnylam’s Safety & Risk Management (SRM) organization within Regulatory Sciences. The role enables pharmacovigilance execution across clinical development and marketed products, with responsibility for integrated planning, governance, resource and capacity strategy, external partner performance, delivery insights, and a large budget. The position reports directly to the Senior Vice President of Global Patient Safety & Risk Management and serves as a strategic advisor to Regulatory Sciences and SRM leadership. It builds and leads a high-performing Pharmacovigilance Operations, Innovation & Analytics team. The role leads operational aspects of the SRM Expertise Area, including pharmacovigilance reporting compliance, safety information case management, scientific knowledge-building support, process innovation, and vendor management. It provides strategic oversight of processes, procedures, systems, compliance, audits and inspections, operational analytics, and external partnerships. The position is hybrid-based, with travel to Alnylam’s U.S. offices in Cambridge, Massachusetts, or Philadelphia, Pennsylvania required. The role is full-time and eligible for annual short-term and long-term incentive awards. The U.S. base salary range listed is $289,000–$391,000. Alnylam describes a comprehensive benefits package that includes medical, dental, and vision coverage; life and disability insurance; a lifestyle reimbursement program; flexible spending and health savings accounts; a 401(k) with company match; paid time off, wellness days, holidays, company-wide recharge breaks, and family resources and leave.

Requirements

Bachelor’s degree in a scientific or healthcare field.
At least 20 years of relevant work experience in pharmacovigilance or a related operational global biotech/pharma role.
Progressive management experience with responsibility encompassing pharmacovigilance, risk management, and quality-related matters.
Experience leading compliance or audits, with working knowledge of relevant FDA, EU, and ICH guidelines and Good Pharmacovigilance Practice (GVP) regulations governing safety reporting and processing in clinical-trial environments, as well as regulatory quality matters.
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 decision-making and organizational transparency.
Exceptional leadership, collaboration, and influencing skills, including success in highly matrixed organizations and with senior leadership teams.
Strong strategic thinking and problem-solving skills, including 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.
Ability to demonstrate and lead in alignment with Alnylam Core Values: Commitment to People, Innovation and Discovery, Sense of Urgency, Open Culture, and Passion for Excellence.

Nice To Haves

MD degree or another senior degree.

Responsibilities

Lead all operational aspects of the Safety and Risk Management (SRM) Expertise Area.
Build and lead high-performing Pharmacovigilance Operations, Innovation & Analytics teams, with strategic oversight and financial soundness.
Provide strategic leadership and oversight of process design, evaluation, and review of SRM procedures, pharmacovigilance operational innovation, and operational excellence.
Foster partnerships with Commercial and Medical Affairs, Clinical Operations, Quality Assurance, Data Management, IT, Finance, and external partners.
Partner with Quality Assurance to manage and conduct audits and inspections effectively and promote a successful pharmacovigilance Quality Management System.
Ensure relevant SOPs, systems, and processes are in place for an efficient and compliant Safety & Risk Management organization.
Provide strategic consultation and guidance to development and commercial/Medical Affairs teams on decisions with significant pharmacovigilance operational implications, including safety-reporting operations for postmarketing studies, market research, and Patient Access programs.
Oversee tracking of KPIs and reporting-compliance metrics related to SRM and Regulatory Quality activities.
Provide strategic leadership and input into pharmacovigilance system requirements and process design, collaborating with IT on efficient, high-quality systems, including Argus, PVReports, and Empirica.
Partner with the QPPV to provide strategic direction and quality and compliance leadership to SRM.
Define and execute the pharmacovigilance vendor strategy, with governance, accountability, speed, quality, and cost efficiency in view.
Manage and assess external partner performance, including Case Management/Medical Review vendors and clinical-trial safety-reporting vendors.
Establish vendor governance frameworks and accountability mechanisms, ensuring delivery meets safety-reporting regulations, obligation timelines, and organizational priorities.
Lead governance of Case Management/Medical Review and other partner relationships, focusing on value realization and risk mitigation.
Advise senior leaders on operating-model design, systems strategy, and execution effectiveness.
Champion collaboration, transparency, accountability, and innovation.
Develop organizational capabilities to scale pharmacovigilance activities across development and commercial products.