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
timelines; accuracy and consistency. Process cases based on these assessmentsReview case criteria to determine appropriate workflow for case processingAssess cases to distinguish those with particular complexities and / or specific issues, and escalate appropriatelyWrite and edit case narrativeDetermine and perform appropriate case follow-up, including generation of follow-up requestsReview processed cases to verify accuracy, consistency and compliance with process requirements, and review case data for special scenariosLiaise with key partners, locally , and other stakeholders regarding safety data collection and data reconciliationDevelop 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 databaseDetermine reportability of scheduled reports , ensuring adherence to regulatory requirementsConsistently apply regulatory requirements and Pfizer policiesParticipate, as appropriate, in local, internal and external safety activities
Technical Skill Requirements
Experience in pharmacovigilance and / or data management preferred but not requiredExperience and skill with medical writing an advantageDemonstrated computer literacyExperience in use and management of relational databases preferred
Qualifications (i.e., preferred education, experience, attributes)
Health Care Professional or equivalent experience preferredAbility, with supervision, to solve routine problems and to surface issues constructivelyAbility to make basic decisions with an understanding of the consequencesAbility to achieve personal objectives while meeting departmental standards of performanceAbility to work under supervision in a matrix organizationFluency in spoken and written English
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.