Manager, Global Patient Safety Scientist

Regeneron Pharmaceuticals • Warren, MA

12d • Onsite

About The Position

The Manager of Global Patient Safety (GPS) is a scientific role supporting safety strategies for molecules in clinical development and post-marketing phases. The work includes aggregating, reviewing, and analyzing safety data to support appropriate safety interpretation and benefit-risk assessment. The role is based in Sleepy Hollow, NY; Warren, NJ; or Cambridge, MA, with an expectation to work onsite four days per week. Travel may be required, approximately 25%.

Requirements

• A master's degree, PharmD, or PhD is required.
• Previous safety or relevant clinical experience in the pharmaceutical industry is required; 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 work with a safety system database for medical case review and simple queries.
• Advanced understanding of safety surveillance activities and principles; the role operates under supervision from more senior members of the GPS safety sciences team.
• Proactive and self-disciplined approach, with the ability to meet deliverables, manage time effectively, and prioritize.
• Effective verbal and written communication skills for communicating safety findings.

Nice To Haves

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

Responsibilities

• Complete signal detection activities in accordance with approved safety surveillance plans.
• Evaluate identified signals and author safety evaluation reports.
• Manage the 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 (SMT) 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 (RSOC), Independent Data Monitoring Committees (IDMC), and teams with members external to Regeneron.
• Use data manipulation and visualization tools, including Excel and pivot tables, for safety analysis.
• Participate in process improvement initiatives, such as 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 coverage, 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