Senior Director Global Patient Safety

Regeneron

Dublin

Hybrid

EUR 180,000 - 240,000

Full time

2 days ago
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Benefits offered by this job

Health insurance
Retirement plan

Job summary

Regeneron Pharmaceuticals, Inc. seeks a Senior Director to join our Global Patient Safety team in a hybrid setting in Ireland.

You will lead safety strategy across assigned compounds, collaborating with cross-functional teams to advance risk management and regulatory responses. You will chair safety governance bodies, mentor junior scientists, and influence senior management while ensuring rigorous pharmacovigilance activities, DSUR/PSUR oversight, and safety communications in a fast-growing

Qualifications

  • Five-plus years’ relevant pharmacovigilance/medical experience with a listed degree.
  • Ten-plus years’ relevant pharmacovigilance/medical experience, or equivalent in lieu of PharmD/PhD/MD.
  • Clinical-development experience with safety achievements (e.g., integrated safety summaries).
  • Ability to influence colleagues across matrix teams, including senior management.

Responsibilities

  • Lead assigned-compound safety activities: surveillance, signal management, lifecycle safety communications, benefit-risk assessment and regulatory responses.
  • Oversee DSURs, PSURs, development Risk Management Plans and Risk Management Plans.
  • Review Investigator Brochures, protocols and clinical study reports.
  • Chair Safety Management/Monitoring Team and represent Global Patient Safety cross-functionally.
  • Deputise for Therapeutic Area Head and develop non-compound safety strategies.
  • Provide ICSR medical-review expertise and review other data sources.
  • Develop SOPs and guides; mentor junior safety scientists and foster cross-functional collaboration.
  • Influence across internal and external matrix teams, including senior management.

Skills

Leadership
Cross-functional
Pharmacovigilance
Safety strategy
Mentoring

Education

Nursing
PharmD
PhD
MD

Job description

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Director to join our Global Patient Safety team, supporting our assigned compounds in a hybrid setting. In this role, you will lead safety strategy while collaborating with cross-functional teams. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where:

Multiple locations are being considered for this role (Hybrid)

Discover your role:

  • 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.

This role requires:

  • 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.

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.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site.

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.

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

  • Location: Tarrytown, United States of America, Basking Ridge, United States of America and 5 other locations
  • Location: Tarrytown, United States of America, Warren, United States of America

We take hiring seriously — because finding the right person for our mission matters as much to us as finding the right company matters to you. Our process is thorough by design: we want every new hire to feel confident they've found a place where their work truly matters, and we want to be just as confident we've found someone who'll thrive here. It's a two-way conversation, not a one-way interview.

Part of the team

Where You'll Make an Impact

Here, you’ll collaborate with teams across regions to help move our mission forward.

We invest in your health and stability so you can focus on making meaningful impact. Below is a highlight of benefit programs that may be available to you, depending on your country of employment, role, etc.

Medical, dental and vision insurance
Life insurance and disability coverage
Global wellness support & benefits access
Paid time off, personal/flexibility hours and holiday leave
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