Senior Manager, Aggregate Reporting Management

Regeneron's Patient Safety organization is seeking a Senior Manager, Aggregate Reporting Management to join our team!

This position in the Global Patient Safety (GPS) Operations is responsible for management of aggregate safety reporting activities across all phases of the product lifecycle. The role supports the consistent, compliant, and scientifically robust preparation, distribution and submission of periodic and ad hoc safety reports to health authorities, collaborators and contract research organizations worldwide.

Responsibilities

• Drive preparation, development and maintenance of aggregate reporting (PSURs/PBRER, PAER, DSURs, Local Periodic Reports, SUSARs).
• Lead aggregate report planning, production and distribution activities across GPS and other functions in the US, EU, Japan and other ICH regions, as well as non ICH regions.
• Provide expertise and guidance to authors and contributors of aggregate reports.
• Maintain compliance metrics and contribute to implementation of Quality Events and Corrective Action and Preventive Action (CAPA) for non compliance.
• Implement effective structure, procedures and tools to ensure aggregate reports and other functional deliverables are completed timely and with high quality.
• Develop and oversee functional specifications of data requirements for aggregate deliverables from the safety and clinical databases.
• Collaborate with Global Patient Safety (GPS) and other functional areas (Epidemiology, Clinical Development, Regulatory Affairs, Statistics, etc.) to contribute to aggregate safety reports.
• Act as subject matter expert during audits and inspections.
• Provide oversight and training as needed of CRO activities to support high quality and timely aggregate reports.
• Act as a functional vendor manager overseeing and driving high quality outputs from vendors.
• Develop and maintain aggregate report procedural packages (SOPs, Work Instructions), report templates and KPIs.
• Drive process improvement through automation and other technology initiatives.

Qualifications

• Bachelor's degree required (advanced degree or HCP focused background preferred) and 5+ years of pharmacovigilance experience with a demonstrated focus on aggregate safety reporting.
• Project management experience strongly preferred; PMP preferred.
• Experience with health authority inspections (PV and GCP).
• Medical writing experience with regulatory documentation.
• Strong project management skills.
• Excellent strategic decision making and analytical skills.
• Strong communication and writing skills.
• Strong understanding of scientific content.
• Proven experience with technology implementations allowing for streamlined process execution.

Benefits

Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role:

• Salary Range (annually) €86,800.00 - €141,200.00.
• Annual bonuses or other incentive plans.
• Equity awards.
• Pension or retirement benefits.
• 401(k) company match.
• Health and wellness programs.
• Fitness centers.
• Insurance benefits (medical, dental, vision, life and disability).
• Paid time off.
• Family support benefits.

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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable state, federal or local laws. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship. Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements may apply and influence certain elements of pay or benefits.