Safety data management specialist

MAIN REPONSIBILITIES / DUTIES:

Review, preparation, and completion of reports of adverse drug experiences, to determine the safety profile of Pfizer’s products and to meet regulatory requirements. Determination of local submission of individual and, where appropriate, aggregate safety reports

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 the appropriate workflow for case processing
- Assess cases to distinguish those with particular complexities and/or specific issues, and escalate appropriately
- Write and edit the 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, for guidelines, Standard Operating Procedures, for data entry conventions, and for 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