Director, Pharmacovigilance & Safety Technology

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.

This role is Hybrid, based in Cambridge, MA with 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 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, EMA, 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.
• Demonstrated ability to operate at both 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 considerations in regulated PV environments, including how to assess use cases, validation needs, compliance risks, and adoption requirements.
• Proven business analysis skills with strong analytical, problem-solving, prioritization, project management, and stakeholder management abilities.
• Strong team player with the ability to influence across Safety, Technology, Quality, Compliance, Data, vendors, and senior business stakeholders.
• Excellent oral and written communication skills, with 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.