Director, Pharmacovigilance & Safety Technology

Overview Alnylam is the world’s leading RNA interference (RNAi) company, dedicated to transforming patients’ lives through innovative medicines. As the global development and commercial portfolio expands, Safety & Risk Management requires scalable, compliant, and data-driven technology capabilities that support high-quality pharmacovigilance across investigational and marketed products. The Director, Pharmacovigilance & Safety Technology shapes and executes the technology strategy for Safety & Risk Management and related safety functions. As the primary business technology leader for Safety, this role ensures that platforms, data, integrations, analytics, reporting, and digital workflows enable compliant, efficient, inspection-ready, and insight-driven operations across the product lifecycle. Reporting to the Executive Director, Commercial & Development Technologies, this role directly manages two experienced technology professionals at the Manager and Senior Manager levels. The role translates Safety priorities into a practical roadmap and leads execution and additional work through its team, product owners, application teams, managed service providers, vendors, and cross-functional partners. Success in this role requires strong pharmacovigilance-domain business acumen, technical fluency across regulated safety platforms, and the ability to translate safety priorities into a practical technology roadmap. The leader will be expected to connect strategy to execution—partnering with Safety leadership, enterprise Technology, Data, Quality, Security, Compliance, Validation, and vendor teams to deliver scalable, compliant, secure, and user-centered solutions. Rather than serving as a single-system product owner or duplicating Safety Operations responsibilities, this role provides functional technology leadership across the broader PV and safety capability landscape. This role is Hybrid, based in Cambridge, MA requiring 2-3 days onsite. Key Responsibilities • Serve as the primary business technology functional leader and strategic partner for Safety & Risk Management, Safety Operations, Pharmacovigilance, Risk Management, and related safety functions, building trusted relationships with functional leadership to understand objectives, priorities, pain points, and technology needs. • Define and maintain the safety technology roadmap, translating Safety business priorities and requirements into prioritized platform investments, process-enabling technology capabilities, data enablement, automation, and AI-enabled solution opportunities. • Lead the technology direction, prioritization, and continuous improvement of platforms and workflows supporting end-to-end pharmacovigilance, including case management, regulatory reporting, signal and risk management, aggregate reporting, safety analytics, and related integrations. • Own the technology partnership model for supported safety functions, including demand shaping, prioritization, business case development, solution alignment, delivery oversight, adoption planning, operational readiness, and value realization. • Establish clear accountability across the Safety technology operating model: Safety owns business outcomes, processes, and requirements, while Technology owns solution strategy, platform oversight, delivery, governance, and operational reliability. • Establish and enforce technology governance, standards, and best practices, including data privacy, security, validation, records management, inspection readiness, 21 CFR Part 11, data integrity, and compliance with global PV regulatory requirements. • Partner with product owners, application teams, service providers, and vendors to align platform priorities, releases, validation, support models, and service performance with Safety business needs. • Lead, coach, and develop a team of technology professionals, establishing clear accountabilities, priorities, performance expectations, and development plans while building an effective operating model across internal teams, vendors, and delivery partners. • PV Systems, Data & Architecture Leadership • Provide technology leadership in the design and evolution of PV systems, safety data models, integrations, reporting architecture, analytics capabilities, dashboards, workflow automation, and platform interoperability across the safety ecosystem. • Partner with Data and Analytics teams to enable cross-system reporting, traceability, compliance metrics, quality performance indicators, signal detection, and safety insights while maintaining clear data ownership, security, privacy, and compliance boundaries. • Enable and govern technology capabilities used by Safety teams for case intake, triage, medical review, narrative support, expedited reporting, aggregate reporting, signal management, risk management, literature surveillance, inspection readiness, and global submission obligations. • Evaluate and govern emerging digital, automation, analytics, and AI-enabled capabilities for PV, balancing business value with validation, compliance, responsible-use, and adoption requirements. • Translate complex technical, safety, regulatory, validation, and compliance considerations into clear guidance, decisions, and tradeoffs for functional leadership and operational teams. • Cross‑Functional & Lifecycle Collaboration • Collaborate closely with Clinical Development, Clinical Operations, Regulatory, Quality, Medical Affairs, Commercial, Patient Services, Data, and enterprise Technology teams to ensure safety systems integrate effectively across the product lifecycle and support both investigational and post-marketing obligations. • Enable global PV operations through technology solutions that scale across regions, affiliates, partners, vendors, products, studies, programs, reporting destinations, and evolving regulatory expectations. • Partner with Quality, Security, Privacy, Records Management, Compliance, Validation, and Safety leadership to ensure technology solutions meet internal procedures, global regulatory expectations, audit requirements, and inspection readiness standards. • Vendor, Platform & Operational Leadership • Collaborate with external safety system vendors, product owners, application support teams, managed service providers, and enterprise technology partners to deliver system implementations, integrations, upgrades, enhancements, migrations, reporting capabilities, and technology-enabled operational improvements for PV and Safety. • Guide delivery and support partners with sufficient functional and technical depth to challenge solution designs, assess architecture and data tradeoffs, and ensure delivered capabilities meet compliance, scalability, usability, integration, and operational support standards. • Proactively identify system, data, reporting, integration, workflow, and technical gaps in safety systems and recommend pragmatic technology improvements that reduce operational burden and strengthen compliance. • Apply root cause analysis to resolve complex technology issues affecting case processing, regulatory reporting, safety data quality, integrations, system performance, or operational delivery. • Act as the technology escalation point for critical system issues impacting PV, Safety Operations, regulatory reporting, signal detection, inspection readiness, or safety business continuity. Qualifications: • Degree in Information Technology, Computer Science, Data Science, Life Sciences, Pharmacy, or related field, with significant experience in regulated life sciences environments. • 12+ years of experience in life sciences technology, pharmacovigilance systems, safety technology, drug safety operations technology, safety data management platforms, PV systems modernization, or related regulated technology roles. • Deep understanding of PV processes sufficient to lead technology design, governance, and delivery across safety databases such