Safety Data Management Specialist

hace 4 semanas


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

Empowering Healthcare Decisions

Pfizer's mission is to connect evidence-based medical decision support with colleagues and stakeholders to enable better health and treatment outcomes. As a Senior Associate, you will play a key role in monitoring the company's drug, biologics, and medical devices surveillance program, including intake, evaluation, and processing of adverse reports received.

Key Responsibilities:

  • Contribute to the completion of complex projects, manage own time to meet agreed targets, and develop plans for work activities on own projects within a team.
  • Provide oversight, team mentoring on case handling aspects, data extraction, and analyses, and conduct follow-up activities.
  • Review, analyze, prepare, and complete safety-related reports within scope to determine the safety profile of Pfizer's products and to meet regulatory requirements.
  • Manage, where applicable, safety resources in the local team.
  • Develop and maintain advanced knowledge of all products within the Pfizer portfolio.
  • Develop and maintain expertise of all assigned products, of applicable corporate policies.
  • Design and oversee the tracking of applicable safety metrics.
  • Manage project and process management meeting established deadlines.
  • And search functions in the safety database and data mart.

**Requirements**:

  • Bachelor's Degree
  • 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 in order to meet strict regulatory compliance goals
  • Fluent in spoken and written English

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.



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