Senior Manager, Global Patient Safety Sciences - Oncology

Regeneron Pharmaceuticals • Warren, MA

3d • $150,500 - $245,500 • Onsite

About The Position

Regeneron is seeking a Senior Manager to join its Patient Safety team. The Senior Manager of Global Patient Safety (GPS) will play a scientific role in developing safety strategies for molecules in clinical development and post-marketing phases within the assigned Therapeutic Area. The role includes aggregating, reviewing, and analyzing safety data to support appropriate safety interpretation and benefit-risk assessment. The position is based in Tarrytown, NY or Warren, NJ, with an expectation to work on site four days per week.

Requirements

• A minimum of a master's degree, PhD, or PharmD.
• Seven or more years of relevant risk management 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 activities in clinical trial and post-marketing environments.
• Ability to use a safety system database for medical case review and simple queries.
• Proactive and self-disciplined approach, with the ability to meet deliverables, manage time effectively, and prioritize.
• Ability to communicate safety findings effectively, verbally and in writing.

Responsibilities

• Complete signal detection activities in line 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 as appropriate for assigned compounds.
• Represent GPS on cross-functional teams when asked, including the Regeneron Safety Oversight Committee (RSOC), Independent Data Monitoring Committees (IDMC), and other teams with external members.
• Participate in process improvement initiatives, including developing and maintaining relevant SOPs, WIs, 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: Senior