Turkey Job Openings
Pfizer
Senior Safety Data Management Specialist
Istanbul
FULL TIME
October 11, 2024
- 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.
- Act as subject matter expert and liaise with key partners regarding safety data collection and data reconciliation.
- Review, analyze, prepare, and complete safety-related reports within scope to determine the safety profile of Pfizer's products and to meet regulatory requirements.
- Review processed cases to verify accuracy, consistency and compliance with process requirements, and review case data for special scenarios.
- Manage, where applicable, safety resources in the local team.
- Provide specific pharmacovigilance or product knowledge and experience, as required by the business, and mentor colleagues accordingly.
- 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.
- Participate, as appropriate, in local, internal and external safety activities
- Carry out case processing activities
- Review, rank, verify, process and document case-related information: event terms; validity, seriousness, special scenarios; timelines; accuracy and consistency. Process cases based on these assessments
- Review case criteria to determine appropriate workflow for case processing
- Assess cases to distinguish those with particular complexities and/or specific issues, and escalate appropriately
- Write and edit case narrative
- Determine and perform appropriate case follow-up, including generation of follow-up requests
- Review processed cases to verify accuracy, consistency and compliance with process requirements, and review case data for special scenarios
- Bachelor's Degree
- Pharmacist
- 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
- Master's degree
- Relevant pharmaceutical industry experience
- Familiarity with management of performance metrics
- Ability to make decisions independently in both routine case processing and unique and/or complex situations, and to resolve issues appropriately to achieve a desired result or impact
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