Senior Manager, Pharmacoepidemiology

About the role

The Senior Manager will manage pharmacoepidemiologic projects and activities with direction in support of marketed and/or development compounds, commensurate with experience/skill, in accordance with global regulations and Regeneron SOPs and working practices.

Responsibilities

• Implement pharmacoepidemiology strategy, generate real-world evidence (RWE), and conduct regulatory-agency required epidemiologic studies for post-marketing commitments (e.g., PASS, PAES, PMR, DUS, effectiveness of REMS and RMMs)
• Contribute to other pharmacoepidemiologic activities as a subject matter expert for assigned marketed / development compound(s) or TAs, including but not limited to: Risk Management Plans; Benefit-Risk analyses; post-approval safety studies that may not be required by a regulatory authority; signal management; responses to regulatory agency queries; regulatory filings, safety surveillance and others
• Represent Pharmacoepidemiology on cross-functional teams, including Safety Monitoring Teams, Clinical Development Teams (including with external partners), Regeneron Safety Oversight Committee, and Independent Data Monitoring Committees as needed
• Manage and/or conduct non-compound specific pharmacoepidemiology activities (e.g., literature review and database queries in support of regulatory filings)
• Participate in process improvement activities within the department and Global Patient Safety (GPS) as needed

Requirements

• MD, PharmD, plus other post-graduate degree in epidemiology or a related field (e.g. MPH, MSc)
• Doctoral degree in epidemiology or a related field, generally with
• Industry/Regulatory experience preferred

Qualifications

• Other post-graduate degree in epidemiology or a related field (e.g. MPH, MSc), generally with 2+ years of relevant experience
• Industry/Regulatory experience preferred

Skills

• Knowledgeable in the latest epidemiologic methods and resources

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.

Pay

$150,500.00 - $245,500.00 annually

Schedule

Remote - United States