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Regeneron Pharmaceuticals

Develops biopharmaceutical therapies for serious diseases

Director Safety Scientist Lead - Rare Disease

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeUxbridge, UKNo salary listed

About the Job

Requirements

  • An advanced degree in life sciences or healthcare is required, along with 12 or more years of pharmacovigilance experience; a focus on Safety Sciences and Rare Disease experience is preferred.
  • Strong attention to detail and the ability to assess and optimize Safety operations processes, drive consistency, and ensure high-quality, compliant execution across activities are required.
  • Strong leadership capabilities and presence, interpersonal skills, verbal and written communication skills, organizational and workload-planning skills, and the ability to manage multiple projects simultaneously are required.

Responsibilities

  • Serve as the first point of contact for Rare Disease operations, including safety data processing, submission creation, and documentation, ensuring completeness, accuracy, and timeliness.
  • Ensure high-quality, compliant execution of safety surveillance, signal management, and aggregate reporting activities across the portfolio.
  • Develop the Safety Scientists team and work with other Directors to drive standardization and consistency in signal-detection execution.
  • Develop common practices, processes, and templates to standardize and ensure consistent execution of core activities, including signal detection and authoring sections of safety documents, across products and therapeutic areas.
  • Ensure compliance and quality management of Safety Sciences Delivery activities, including compliance with regulations and establishment of standard operating procedures and associated monitoring tools.
  • Lead signal-detection coordination and the signal-management process across Rare Disease, including Safety Monitoring Team, Safety Surveillance Plan, and Signal Evaluation Report activities.
  • Develop innovative approaches to core activities that integrate new technologies.
  • Analyze aggregate safety data to identify emerging safety issues and patterns in partnership with Safety Sciences Strategy.
  • Coordinate cross-functionally to deliver high-quality, timely, and compliant benefit-risk assessments for periodic safety reports, including DSURs and PSURs, and support Safety Sciences Strategy in providing Medical and Safety perspectives for GPS portfolio documents, including ARM, RMP, and SMP, as required.
  • Drive development and implementation of training programs for GPS staff, including maintaining a standardized Safety Sciences training curriculum, proficiency matrix, and knowledge-management repository across Strategy and Delivery.
  • Serve as the main point of contact for liaison with Safety Sciences Strategy Rare Disease GPS Leads.
  • Collaborate with Clinical, Regulatory, Medical Affairs, Biostatistics, and Data Management interfaces.
  • Build, coach, and scale a high-performing team, and drive succession planning and talent pipelines.
  • Implement talent strategy and leadership-development initiatives that raise capabilities across the organization.

Desired Qualifications

  • Experience overseeing operations within a global patient safety organization is preferred.
  • Experience with artificial intelligence technologies is preferred.
  • Experience leading a matrixed role across multiple areas of an organization and people-management experience are preferred.
  • A focus on Safety Sciences and Rare Disease experience is preferred.

About the Company

Regeneron Pharmaceuticals

Develops biopharmaceutical therapies for serious diseases

Regeneron Pharmaceuticals develops and commercializes medicines for serious diseases, with a focus on cancer, eye diseases, allergic and inflammatory diseases, and infectious diseases. Its products come from using proprietary research capabilities and technologies to discover and develop therapies, often in collaboration with academic, research, and industry partners. Revenue comes from selling approved medicines and from licensing its technologies and entering co-development and co-commercialization partnerships. The company works with healthcare providers and regulators to ensure treatment delivery and safety. Its goal is to improve patient outcomes by bringing life-transforming medicines to market through rigorous R&D and strategic collaborations, maintaining leadership in biopharmaceutical innovation.

Company size
10,001+
Company stage
IPO
Headquarters
Town of Mount Pleasant, New York
Founded
1988

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