Executive Director, Pharmacovigilance Systems & Enablement

BioSpace; Cambridge (MA); On-site; USD 255,000 - 425,000; Full time

Job summary

Regeneron is seeking an Executive Director to lead Global Patient Safety (GPS) PV systems and enablement, owning the domain requirements, data architecture, PV processes, and AI-enabled capabilities across GPS while maintaining GxP compliance and day-to-day operational reliability.

You will define and execute a forward-thinking PV systems strategy, partner with GD-IT and the AI CoE, translate business needs into system specs, and build a high-performing team.

Qualifications

• Minimum Bachelor's Degree with 17+ years in pharmacovigilance or PV systems.
• Deep understanding of PV processes, safety databases, and reporting tools.
• Strong knowledge of AI and analytics in regulated PV environments.
• Ability to design PV systems and AI-enabled solutions compliant with global regulations.
• Experience leading cross-functional Safety, IT and data/AI teams.
• Familiarity with AI governance, validation, and compliance for PV systems.

Responsibilities

• Serve as domain PV expert on safety data, processes, and regulations across GPS.
• Define and own GPS PV systems forward-looking strategy and AI-enabled capabilities.
• Define and communicate the functions vision aligned with enterprise goals.
• Collaborate with GPS leads to align priorities and develop an integrated roadmap.
• Engage with GD-IT and technology teams to execute the GPS roadmap.
• Own and maintain GPS PV systems roadmap balancing modernization and compliance.
• Identify opportunities to leverage AI and analytics within PV processes.
• Oversee AI governance, validation, and implementation.
• Ensure PV systems comply with GxP and data integrity.
• Translate requirements into PV systems specs with stakeholders.
• Provide strategic oversight of PV systems like databases and analytics platforms.
• Liaise with enterprise technology partners representing PV systems.
• Oversee vendor performance and PV systems modernization delivery.
• Build and scale a high-performing team; talent strategy.

Skills

PV systems

AI in PV

Data architecture

Cross-functional leadership

Regulatory compliance

Vendor management

Education

Bachelor's degree

MS preferred

Job description

Build Our Future Together

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking an Executive Director to join our Global Patient Safety team.

Build Our Future Together

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking an Executive Director to join our Global Patient Safety team.

The Executive Director, PV Systems & Enablement serves as GPS forward-looking pharmacovigilance (PV) domain expert for PV systems and ways of working. This role owns the domain requirements of PV systems, data architecture, PV processes, and AI-enabled capabilities across all of GPS, proactively identifying and proposing modern, innovative, defensible ways of working in a GxP environment. Responsibilities span PV systems forward looking strategy, first-pass prioritization and domain assessment of AI use cases in partnership with the enterprise AI Center of Excellence (CoE), and partnership with GD-IT and other technology teams to execute the resulting roadmap, while maintaining GxP compliance and day-to-day operational reliability of existing systems.

This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & Where

Work Location: Tarrytown, NY, Warren, NJ or Cambridge, MA
4 days per week on site
25% Travel may be required

Discover Your Role

• Serve as a domain pharmacovigilance (PV) expert on safety data, process and regulations across all of Global Patient Safety (GPS), proactively identifying and proposing modern, innovative, defensible ways of working in a GxP environment.
• Define and own the PV systems forward looking strategy for GPS, including PV technology systems, data architecture, and AI-enabled capabilities (e.g., agentic AI, Claude, Copilot), partnering with GD-IT and other technology teams on execution
• Define and communicate the functions vision and strategy in alignment with enterprise goals and business priorities.
• Collaborate with GPS functional leads to align priorities, identify enabling capabilities and develop a single, integrated roadmap that meets patient safety requirements.
• Engage, partner with GD-IT and other technology teams across Regeneron as the PV domain owner, defining requirements, priorities, and dependencies for the GPS roadmap while GD-IT owns technical execution.
• Own and maintain the GPS PV systems roadmap, balancing modernization initiatives with operational sustainability and regulatory compliance.
• Identify opportunities to leverage AI and advanced analytics within PV processes and guide the teams in the appropriate solution design, validation and implementation of those solutions.
• Conduct first-pass domain review and prioritization of AI use cases for GPS, partnering with the enterprise AI Center of Excellence (CoE), which owns formal AI governance.
• Oversee implementation and drive user adoption of AI across GPS, including ongoing compliance and responsible use of AI.
• Ensure new PV systems and ways of working are compliant with all GxP, validation, and data integrity requirements, and are defensible under regulatory inspection.
• Translate business requirements into clear PV systems specifications in partnership with GPS functional leaders, GD IT, and other stakeholders.
• Provide strategic oversight of PV systems (e.g., safety databases, signal detection tools, analytics platforms) to ensure alignment with GPS strategy and operational needs
• Serve as primary GPS liaison with enterprise technology partners (e.g., GD IT, Cloud, Dev Ops, AI CoE, Compliance), representing PV systems and domain requirements.
• Oversee system vendor performance, contract management, and PV systems modernization project delivery
• Build, coach, and scale a high-performing team.
• Lead talent strategy and leadership development initiatives that raise capabilities across the organization.
• Influence cross-functional leaders to align PV priorities and drive enterprise results that benefit GPS and the broader Regeneron organization.

This Role Requires

• Minimum Bachelors Degree (MS preferred) with 17+ years of experience in pharmacovigilance, safety systems, PV systems modernization, data science, or AI-enabled capabilities within the life sciences industry
• Deep understanding of PV processes and systems, including safety databases, signal detection tools, and reporting platforms.
• Strong knowledge of AI and advanced analytic applications within PV regulated environments.
• Ability to assess, prioritize, and design PV systems and AI-enabled solutions in compliance with global regulatory and quality expectations, in partnership with the enterprise AI CoE and other cross-functional partners.
• Demonstrated experience modernizing PV systems and safety operations, including implementation of AI-enabled or other new PV capabilities in regulated environments.
• Experience leading cross-functional initiatives involving Safety, IT, and data/AI teams.
• Familiarity with AI governance frameworks (partnering with an enterprise AI CoE), validation, and compliance considerations for PV systems in regulated environments.

Does this sound like you? We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.

For jobs in Canada: this posting is for an existing position.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

Salary Range (annually)

$255,000.00 - $424,900.00