Primary 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, 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 (i.e., preferred education, experience, attributes)

·         Health Care Professional or equivalent experience preferred

·         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