Safety Data Management Specialist

Role Purpose


Examine, prepare, and finalize reports on adverse drug experiences to establish the safety profile of Pfizer's products and meet regulatory requirements. Determine local submission of individual and, where appropriate, aggregate safety reports.


Key Responsibilities


Execute case processing activities.
Evaluate, categorize, verify, process, and document case-related information: event terms; validity, seriousness, special scenarios; timelines; accuracy and consistency. Handle cases based on these assessments.
Analyze case criteria to determine appropriate workflow for case processing.
Identify cases with particular complexities and/or specific issues and escalate as needed.
Compose and edit case narratives.
Identify and perform appropriate case follow-up, including generating follow-up requests.
Examine processed cases to ensure accuracy, consistency, and compliance with process requirements, and review case data for special scenarios.
Collaborate with key partners, locally, and other stakeholders regarding safety data collection and reconciliation.
Cultivate and maintain expertise in applicable corporate and global regulations, guidelines, Standard Operating Procedures, data entry conventions, and search functions in the safety database.
Assess reportability of scheduled reports, ensuring adherence to regulatory requirements.
Consistently apply regulatory requirements and Pfizer policies
Engage, as appropriate, in local, internal, and external safety activities


Technical Skill Requirements


Experience in pharmacovigilance and/or data management preferred but not mandatory.
Experience and proficiency in medical writing is beneficial
Proven computer literacy.
Experience in using and managing relational databases is preferred


Qualifications (i.e., Preferred Education, Experience, Attributes)


Health Care Professional or equivalent experience preferred.
Capability, with supervision, to resolve routine issues and constructively address problems.
Ability to make fundamental decisions with an understanding of their implications.
Capacity to achieve personal objectives while meeting departmental performance standards.
Ability to work under supervision in a matrix organization.
Fluency in spoken and written English