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Data Safety Management Specialist

hace 2 semanas

San José, San José, Costa Rica Pfizer A tiempo completo

Pfizer's mission is to empower healthcare decisions regarding the safe and appropriate use of medicines for patients.

The role of a Senior Associate in our Medical and Safety team is crucial in connecting evidenced-based medical decision support with colleagues and stakeholders to enable better health and treatment outcomes. This involves creating frameworks to ensure our evidence is scientifically sound, providing unbiased medically necessary expertise, and investigating data gaps.

This position requires monitoring Pfizer's drug, biologics, and medical devices surveillance program, including intake, evaluation, and processing of adverse reports received. As a Senior Associate, you will support clinical trial activities and post-marketing tasks, contributing towards the goals and objectives of the team.

To succeed in this role, you will be responsible for:

  • Completing complex projects on time, managing your own time effectively, and developing plans for work activities within a team.
  • Providing oversight, team mentoring on case handling aspects, data extraction and analysis, and conducting follow-up activities.
  • Reviewing, analyzing, preparing, and completing safety-related reports to determine the safety profile of Pfizer's products and meet regulatory requirements.
  • Verifying accuracy, consistency, and compliance with process requirements for processed cases and reviewing case data for special scenarios.
  • Managing safety resources in the local team, where applicable.
  • Providing specific pharmacovigilance or product knowledge and experience as required by the business and mentoring colleagues accordingly.
  • Developing and maintaining advanced knowledge of all products within the Pfizer portfolio and expertise of assigned products and corporate policies.
  • Designing and overseeing the tracking of applicable safety metrics and managing project and process management meeting established deadlines.
  • Searching functions in the safety database and data mart.

Key qualifications for this role include:

  • Bachelor's Degree in Health Science
  • 3+ years' experience
  • Demonstrated organizational/project management skills
  • Solid knowledge of global regulations and guidelines for drug development
  • Demonstrated analytical and statistical skill
  • Ability to make decisions independently and resolve issues appropriately
  • Strong skills in productivity, organizational, and time management to meet strict regulatory compliance goals
  • Fluent in spoken and written English