Manager, Global Patient Safety Scientist

Regeneron Pharmaceuticals • Cambridge, MA

18d • $114,800 - $187,400 • Onsite

About The Position

The Manager of Global Patient Safety (GPS) will provide scientific support for safety strategies for molecules in clinical development and post-marketing phases. The role involves aggregating, reviewing, and analyzing safety data to support appropriate safety interpretation and benefit-risk assessment. The position is part of Regeneron’s Global Patient Safety Sciences team and is based at one of the listed locations, with four days per week onsite and travel that may reach 25%.

Requirements

• A minimum of a master's degree, PharmD, or PhD.
• Previous safety or relevant clinical experience in the pharmaceutical industry.
• Typically, at least 5 years of risk management or relevant clinical experience in the pharmaceutical or biotechnology industry, or at a health authority.
• Ability to apply relevant FDA, EU, and ICH guidelines, initiatives, and regulations governing pharmacovigilance in clinical trial and post-marketing environments.
• Ability to use a safety system database for medical case review and simple queries.
• Advanced understanding of safety surveillance activities and principles; the role continues to operate under supervision by more senior GPS safety sciences team members.
• Ability to be proactive and self-disciplined, meet deliverables, manage time effectively, and prioritize.
• Ability to communicate safety findings effectively, both verbally and in writing.

Nice To Haves

• Clinical and/or industry experience in the therapeutic area of interest.

Responsibilities

• Complete signal detection activities in line with approved safety surveillance plans.
• Evaluate identified signals and author safety evaluation reports.
• Manage preparation and review of safety documents, including DSURs, PSURs, RMPs, and responses to health authority or other queries.
• Prepare and deliver presentations at Signal Management Team meetings.
• Participate in clinical study team meetings for assigned compounds.
• Participate in other risk management activities for assigned compounds, as appropriate.
• Represent GPS on cross-functional teams, potentially including the Regeneron Safety Oversight Committee, Independent Data Monitoring Committees, and teams with external members.
• Manipulate and visualize data, including using Excel and pivot tables, for safety analysis.
• Participate in process improvement initiatives, including developing and maintaining relevant SOPs, work instructions, and supporting documents.

Benefits

• Annual bonuses or other incentive plans may be offered, depending on country and role.
• Equity awards may be offered, depending on country and role.
• Pension or retirement benefits may be offered, depending on country and role.
• 401(k) company match may be offered, depending on country and role.
• Health and wellness programs may be offered, depending on country and role.
• Fitness centers may be available, depending on country and role.
• Insurance benefits, including medical, dental, vision, life, and disability insurance, may be offered, depending on country and role.
• Paid time off may be offered, depending on country and role.
• Family support benefits may be offered, depending on country and role.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager