Safety Data Management Specialist
hace 4 semanas
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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