Senior Manager, Global Patient Safety - General Medicine

Regeneron Pharmaceuticals; Warren (MI); On-site; USD 151,000 - 246,000; Full time

Job summary

Regeneron Pharmaceuticals is seeking a Senior Manager of Global Patient Safety to lead safety strategies for molecules in development and post-marketing. The role focuses on safety data aggregation, interpretation, and benefit-risk assessment across therapeutic areas.

The position involves signal detection and evaluation, preparation of safety documents (DSUR, PSUR, RMP), presenting at SMT meetings, and cross-functional collaboration with RSOC and IDMC teams.

Qualifications

• Master’s, PhD, or PharmD required.
• 7+ years of risk management experience in the pharmaceutical/biotech industry or health authority.

Responsibilities

• Lead signal detection and evaluation activities per safety plan.
• Prepare DSUR, PSUR, and RMP and respond to health authority queries.
• Present at Signal Management Team meetings and participate in clinical study teams.
• Represent GPS on cross-functional teams (RSOC, IDMC) and other external teams.
• Drive process improvements; develop SOPs and supporting documents.

Skills

Regulatory guidelines

Safety database

Proactive mindset

Communication skills

Education

Master’s/PhD/PharmD

Job description

The Senior Manager of Global Patient Safety (GPS) will play a key scientific role in safety strategies for molecules in clinical development and post-marketing phases in the assigned Therapeutic Area. We will expect this to include safety data aggregation, review and analysis to support appropriate safety interpretation and benefit-risk assessment.

In this role, a typical day might include:

• Complete signal detection activities in line with approved safety surveillance plan

• Perform signal evaluation for any identified signals and author the safety evaluation reports

• Manage preparation and review of safety documents including DSUR, PSUR, RMP, response to health authority or other queries

• Prepare and deliver presentations at Signal Management Team (SMT) meetings; participate in clinical study team meetings for assigned compounds

• Participate in other risk management activities as appropriate for assigned compounds

• We may ask you to represent GPS on cross-functional teams, including Regeneron Safety Oversight Committee (RSOC), Independent Data Monitoring Committees (IDMC) and other teams with members external to Regeneron

• Actively participate in process improvement initiatives e.g. the development and maintenance of relevant SOPs, WIs and supporting documents

This role might be for you if can/have the:

• Ability to apply relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments

• Ability to work with a safety system database for purposes of medical case review and simple queries

• Able to be proactive and self-disciplined, you can meet deliverables, and effectively use your time and prioritize

• Ability to effectively communicate (verbal and written) safety findings

To be considered for this opportunity, you must have the following:

• Minimum a Master’s, PhD, or PharmD

• Offers 7+ years of relevant risk management experience in the pharmaceutical/ biotech industry or health authority

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We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centres, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! Please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/ for additional information about Regeneron benefits in the US. For other countries’ specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.

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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company’s business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)

$150,500.00 - $245,500.00