Director, Pharmacovigilance & Safety Technology

Alnylam Pharmaceuticals•Cambridge, MA

2h•Hybrid

About The Position

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 support compliant, efficient, inspection-ready, and insight-driven pharmacovigilance across investigational and marketed products. Reporting to the Executive Director, Commercial & Development Technologies, the Director directly manages two experienced technology professionals at the Manager and Senior Manager levels. The role translates Safety priorities into a practical technology roadmap and leads execution through its team, product owners, application teams, managed service providers, vendors, and cross-functional partners. It provides functional technology leadership across the broader PV and safety capability landscape rather than serving as a single-system product owner or duplicating Safety Operations responsibilities. The role partners with Safety leadership and enterprise Technology, Data, Quality, Security, Compliance, Validation, and vendor teams to deliver scalable, compliant, secure, user-centered solutions. It provides leadership across PV systems, data models, integrations, reporting architecture, analytics, dashboards, automation, platform interoperability, vendor and platform management, and operational support. This is a hybrid role based in Cambridge, Massachusetts, with 2–3 days onsite.

Requirements

Degree in Information Technology, Computer Science, Data Science, Life Sciences, Pharmacy, or a related field, with significant experience in regulated life sciences environments.
At least 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 as Argus or comparable commercial safety platforms, case intake and processing workflows, regulatory reporting, signal detection tools, aggregate reporting, risk management, and safety analytics.
Working knowledge of global pharmacovigilance regulatory requirements and industry standards, including FDA and EMA requirements, ICH guidelines, 21 CFR Part 11, GxP validation, data integrity, MedDRA structure, and inspection-readiness expectations.
Significant experience shaping technology strategy and capability roadmaps in GxP-regulated environments, ideally across platforms, processes, data, integrations, reporting, and analytics workflows.
Ability to work at strategic and technical depth, including evaluating architecture options, validation approaches, data integration strategies, reporting tools, vendor solutions, and operational support models.
Experience with PV technologies and adjacent tools such as safety gateways, reporting platforms, dashboards, Oracle or SQL-based data environments, analytics platforms, signal detection tools such as Empirica or Spotfire, and enterprise integration services.
Strong understanding of AI, automation, advanced analytics, and responsible AI governance in regulated PV environments, including use-case assessment, validation needs, compliance risks, and adoption requirements.
Proven business analysis skills and strong analytical, problem-solving, prioritization, project management, and stakeholder management abilities.
Ability to influence across Safety, Technology, Quality, Compliance, Data, vendors, and senior business stakeholders.
Excellent oral and written communication skills, including the ability to translate technical, regulatory, and compliance topics into clear business decisions and executive-ready recommendations.
Demonstrated people leadership experience, including direct responsibility for coaching, developing, and managing experienced technology professionals and building high-performing internal and partner delivery teams.

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.
Define and maintain the safety technology roadmap, translating business priorities into platform investments, process-enabling capabilities, data enablement, automation, and AI-enabled opportunities.
Lead 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 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 accountability across the Safety technology operating model, distinguishing Safety ownership of business outcomes, processes, and requirements from Technology ownership of solution strategy, platform oversight, delivery, governance, and operational reliability.
Establish and enforce technology governance, standards, and best practices for data privacy, security, validation, records management, inspection readiness, 21 CFR Part 11, data integrity, and global PV regulatory compliance.
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 technology professionals by setting accountabilities, priorities, performance expectations, and development plans, and by building an effective operating model across internal teams, vendors, and delivery partners.
Provide technology leadership in the design and evolution of PV systems, safety data models, integrations, reporting architecture, analytics, dashboards, workflow automation, and platform interoperability.
Partner with Data and Analytics teams to enable cross-system reporting, traceability, compliance metrics, quality performance indicators, signal detection, and safety insights while maintaining data ownership, security, privacy, and compliance boundaries.
Enable and govern technology capabilities supporting case intake, triage, medical review, narrative support, expedited reporting, aggregate reporting, signal and risk management, literature surveillance, inspection readiness, and global submissions.
Evaluate and govern emerging digital, automation, analytics, and AI-enabled PV capabilities, balancing business value with validation, compliance, responsible use, and adoption requirements.
Translate technical, safety, regulatory, validation, and compliance considerations into clear guidance, decisions, and tradeoffs for functional leadership and operational teams.
Collaborate with Clinical Development, Clinical Operations, Regulatory, Quality, Medical Affairs, Commercial, Patient Services, Data, and enterprise Technology teams to integrate safety systems across the product lifecycle and support 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 meet internal procedures, regulatory expectations, audit requirements, and inspection-readiness standards.
Collaborate with external safety system vendors, product owners, application support teams, managed service providers, and enterprise technology partners on implementations, integrations, upgrades, enhancements, migrations, reporting, and operational improvements.
Guide delivery and support partners in assessing solution designs, architecture and data tradeoffs, and compliance, scalability, usability, integration, and operational support standards.
Identify system, data, reporting, integration, workflow, and technical gaps and recommend improvements that reduce operational burden and strengthen compliance.
Apply root cause analysis to resolve technology issues affecting case processing, regulatory reporting, safety data quality, integrations, system performance, or operational delivery.
Act as the technology escalation point for critical issues affecting PV, Safety Operations, regulatory reporting, signal detection, inspection readiness, or safety business continuity.