Safety Data Managment Specialist

Primary Responsabilities - 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

Technical Skill Requirements

- Experience in pharmacovigilance and/or data management preferred but not required
- Experience and skill with medical writing an advantage
- Demonstrated computer literacy

Experience in use and management of relational databases preferred

Qualifications

- Health Care Professional or equivalent experience (REQUIRED)
- Ability, with supervision, to solve routine problems and to surface issues constructively
- Ability to make basic decisions with an understanding of the consequences
- Ability to achieve personal objectives while meeting departmental standards of performance
- Ability to work under supervision in a matrix organization

Fluency in spoken and written English

#LI-PFE

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

Medical