Senior Director, Global Patient Safety Strategy

Regeneron Pharmaceuticals; Dublin; Hybrid; EUR 144,000 - 240,000; Full time

Job summary

Regeneron Pharmaceuticals seeks a Senior Director to join our Global Patient Safety team, supporting assigned compounds in a hybrid setting. You will lead safety strategy, oversee safety reports, and chair the Safety Management/Monitoring Team while coordinating with internal and external partners.

You will possess strong pharmacovigilance experience, mentor junior scientists, and influence senior management across matrix teams.

Qualifications

• Nursing, PharmD, PhD or MD degree.
• Five-plus years’ relevant pharmacovigilance and/or medical experience with a listed degree.
• Ten-plus years’ relevant pharmacovigilance/medical experience, or equivalent in lieu of PharmD/PhD/MD, including significant drug-safety reporting and risk-management experience.
• Alternatively, clinical-development experience with demonstrated safety achievements, such as integrated safety summary support or clinical study report content responsibility.
• Ability to influence colleagues across matrix teams, including senior management.
• Clinical and/or industry experience in the relevant therapeutic area is a plus.

Responsibilities

• Lead assigned-compound safety activities: surveillance, signal management, lifecycle-appropriate safety communication, benefit-risk assessment and regulatory responses.
• Oversee Development Safety Update Reports, Periodic Safety Update Reports, development Risk Management Plans and Risk Management Plans.
• Review Investigator Brochures, protocols and clinical study reports.
• Chair the Safety Management/Monitoring Team as the first safety contact, coordinating internal support and representing Global Patient Safety cross-functionally.
• Represent safety on the Strategic Program Team, Regeneron’s Safety Oversight Committee, Independent Data Monitoring Committees and partner/contract research organisation teams.
• Deputise for the Therapeutic Area Head and develop non-compound safety strategies, including mechanism-of-action planning.
• Provide complex Individual Case Safety Report medical-review expertise and review other compound data sources.
• Develop standard operating procedures, working practices and guides through continuous improvement, cross-functional relationships and junior safety scientist mentoring.
• You influence collaboratively across internal and external matrix teams, including senior management.

Skills

Pharmacovigilance

Medical experience

Cross-functional leadership

Regulatory liaison

Education

Nursing/PharmD/PhD/MD degree

Job description

Regeneron Pharmaceuticals seeks a Senior Director to join our Global Patient Safety team, supporting assigned compounds in a hybrid setting. You will lead safety strategy, oversee safety reports, and chair the Safety Management/Monitoring Team while coordinating with internal and external partners.

You will possess strong pharmacovigilance experience, mentor junior scientists, and influence senior management across matrix teams.