Regeneron Pharmaceuticals, Inc

Senior Manager, Aggregate Reporting Management

Regeneron Pharmaceuticals, Inc • $134K — $219K *
Warren, MI 48089Hybrid
Pharmaceuticals & Biotech
5 - 7 years of experience
1 month ago
Job Overview by Ladders

Qualifications

  • Bachelor’s degree required, advanced degree or HCP-focused background preferred.
  • 5+ years of Pharmacovigilance experience with emphasis on Aggregate Safety Reporting.
  • Project management experience strongly preferred, PMP certification a plus.
  • Experience with health authority inspections (PV and GCP).
  • Medical writing experience with regulatory documentation is essential.
  • Strong project management, strategic decision-making, and analytical skills required.
  • Excellent communication and writing abilities.

Responsibilities

  • Drive development and maintenance of Aggregate Reporting deliverables.
  • Lead planning, production, and distribution activities for aggregate reports globally.
  • Provide expertise and guidance to aggregate report authors and contributors.
  • Maintain compliance metrics and support Quality Events and CAPA implementation.
  • Implement structures and tools for timely, high-quality report completion.
  • Oversee functional specifications for data requirements from safety databases.
  • Collaborate with GPS and other functions to contribute to aggregate reports.
  • Act as subject matter expert during audits and inspections.
  • Provide oversight and training for CRO activities to ensure quality outputs.
  • Manage vendors for delivering high-quality aggregate reporting.
  • Drive process improvement initiatives through automation and technology.

Benefits

  • Collaborative and innovative work environment.
  • Opportunities for professional development and training.
  • Engagement in impactful global projects.
  • Comprehensive health benefits package.
  • Flexible work arrangements may be available.
Full Job Description

In this role, a typical day might include:

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. This 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.

This role might be for you if you can/have:

  • Drives preparation, development and maintenance of Aggregate Reporting (i.e., PSURs/PBRER, PAER, DSURs, Local Periodic Reports, SUSARs) Deliverables

  • Leads Aggregate Report planning, production and distribution activities across GPS and other functions across US, EU, Japan and other ICH regions, as well as non-ICH regions

  • Provides expertise and guidance to authors and contributors of aggregate reports

  • Maintains compliance metrics and contributes to implementation of Quality Events and Corrective Action and Preventive Action (CAPA) for non-compliance

  • Implements effective structure, procedures and tools to ensure aggregate reports and other functional deliverables are completed timely and with high quality

  • Develops and oversees functional specifications of data requirements for aggregate deliverables from the safety and clinical databases

  • Collaborates with Global Patient Safety (GPS) and with other functional areas (Epidemiology, Clinical Development, Regulatory Affairs, Statistics, etc.) contributing to aggregate safety reports

  • Acts as subject matter expert during audits and inspection.

  • Provides oversight, and training as needed of CRO respective activities in support of high quality and timely aggregate reports

  • Acts as a functional vendor management overseeing and driving high quality outputs from our vendors

  • Develops and maintains aggregate report procedural package (SOPs, Work Instructions), reports’ templates, KPIs

  • Drives process improvement through automation and other tech initiatives.

To be considered for this opportunity, you must have the following:

  • 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.

#GDPSJobs

$134,400.00 - $219,200.00

About Regeneron Pharmaceuticals, Inc

Regeneron Pharmaceuticals is a biopharmaceutical company that discovers, develops, and commercializes pharmaceutical products for the treatment of serious medical conditions. The Company has therapeutic candidates in clinical trials for the potential treatment of cancer, eye diseases, and inflammatory diseases, and has preclinical programs in other diseases and disorders. The company’s product portfolio includes EYLEA, an aflibercept injection; ARCALYST, a rilonacept Injection for subcutaneous use; ZALTRAP for metastatic colorectal cancer; trap fusion proteins; and fully human monoclonal antibodies. On March 26, 2012, it was announced that Sanofi and Regeneron are in development with a new cholesterol drug which will help reduce cholesterol up to 72%. Regeneron Pharmaceuticals was founded in 1988 and is currently headquartered in New York, USA.

Regeneron Pharmaceuticals, Inc Careers

Join the innovative team at Regeneron Pharmaceuticals, Inc, a leading biotechnology company renowned for its commitment to science-driven solutions. This is an unparalleled opportunity to advance your career with a company at the forefront of medical breakthroughs and clinical research.

Work You’ll Do

At Regeneron Pharmaceuticals, Inc, you will collaborate with some of the brightest minds in the industry, engaging in work that directly contributes to the health and well-being of populations globally. Our diverse team of professionals is dedicated to pioneering developments in biotechnology through continuous innovation and rigorous research.

Explore Job Opportunities and Growth

Regeneron offers a variety of job opportunities that encourage professional growth and personal achievement. Whether you're seeking an entry-level position or a more senior role, you will find a path that aligns with your career ambitions and skills. Our supportive culture emphasizes leadership development and diversity training, ensuring every team member can thrive.

Internship Programs

Kickstart your career with a Regeneron internship. Our programs provide invaluable industry experience, mentoring from seasoned professionals, and opportunities to develop skills that are crucial in the biotech field. Interns at Regeneron gain hands-on experience, contributing to projects that matter.

Benefits and Culture

Choosing to work at Regeneron Pharmaceuticals, Inc means choosing a career that comes with competitive benefits designed to support you both professionally and personally. We offer comprehensive health benefits, retirement plans, and wellness programs. Our inclusive culture fosters an environment where every employee can flourish, driven by collaboration and mutual respect.

Innovation and Leadership

Lead the way in biotechnological innovation with Regeneron. Our leadership is constantly looking towards the future, investing in cutting-edge technology and research that pave the way for medical advancements. At Regeneron, leadership and innovation go hand in hand, creating a dynamic where breakthroughs are common.

Networking and Professional Development

Enhance your professional network and skill set through Regeneron’s extensive networking opportunities and ongoing professional development programs. We believe in nurturing our talent with advanced training sessions and regular workshops that cover the latest trends and technologies in the biotech industry.

Join Our Team

Discover the impact you can make in a career at Regeneron Pharmaceuticals, Inc. Search for open positions that match your skills and interests. We are continuously hiring and looking for passionate, curious, and innovative team players.

Stay Connected

Keep up to date with the latest at Regeneron by following our careers blog. Gain insights from the experts and learn more about the exciting world of biotech at Regeneron Pharmaceuticals, Inc.

Prepare for Your Interview

Ready to join us? Prepare your resume and refine your interview skills to become part of a company that’s dedicated to changing lives. Personalize your job search and get tailored job alerts directly to your inbox, so you never miss an opportunity to be part of our team. At Regeneron Pharmaceuticals, Inc, your career is poised for tremendous growth and innovation. Explore the opportunities today and be part of a team that’s shaping the future of biotechnology.
Learn more about Regeneron Pharmaceuticals, Inc
Size
10,368 employees
Market Cap
$78.1 billion
Industry
Pharmaceuticals & Biotech
Net Income
$3.5 billion
Founded
1988
5 Year Trend
+27%
Revenue
$8.4 billion
NASDAQ
REGN
* Ladders Estimates

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