Pfizer Pharma Associate Job Openings – Safety Data Management Role
Associate – Safety Data Management Specialist
Locations: India – Chennai
Time Type: Full time
Posted on: Posted 2 Days Ago
Job Requisition ID: 4908042
Job Responsibilities:
- 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.
- Liaise with key partners, locally, and other stakeholders regarding safety data collection and data reconciliation.
- Develop and maintain expertise and knowledge for applicable corporate and global regulations, guidelines, Standard Operating Procedures, data entry conventions, and search functions in the safety database.
- Determine reportability of scheduled reports, ensuring adherence to regulatory requirements.
- Consistently apply regulatory requirements and Pfizer policies.
- Participate, as appropriate, in local, internal, and external safety activities.
Qualification & Experience:
B. Pharm./ M.Pharm. / Pharm D graduates with 2-3 years of experience in ICSR case processing.
Must have:
- Meticulous attention to detail and accuracy.
- Good written communication skills.
- Analytical and problem-solving skills.
- Proficient in medical terminology.
- Knowledge of ICSR processing guidelines and regulations.
Nice to have:
- Knowledge of event assessment.
- Working experience in ARGUS database.
Work Location Assignment: On Premise
Apply now by visiting the original notification.
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