Organizational Relationship(s) including to whom the position reports to:
Case Processing Team Lead
Position Purpose
Review, preparation, and completion of reports of adverse drug experiences, to determine the safety profile of Pfizer’s products and to meet regulatory requirements.
Primary Responsibilities
Identify and select routine cases for processing, determining appropriate prioritization criteria, and noting reasons for any delays.
Assess cases to distinguish those with particular complexities and/or specific issues, and escalate appropriately.
Review, rank, verify, process and document: event terms; case classifications (validity, seriousness, expectedness/listedness/labeledness); special scenarios; product complaint information; reportability with due date; and accuracy and consistency. Based on assessment of cases, process accordingly.
Review case criteria to determine the appropriate workflow for case processing.
Write and edit the case narrative.
Generate reports, ensuring adherence to regulatory compliance timelines.
Determine appropriate case follow-up, requesting follow-up letters when appropriate. Liaise with key partners, including Pfizer Country Organizations, Clinical Development, License Partners, and other stakeholders regarding safety data collection and data reconciliation.
Develop and maintain expertise and knowledge of all products within the Pfizer portfolio; applicable corporate and global regulations, guidelines, Standard Operating Procedures and writing practices; data entry conventions; and search functions in the safety database.
Consistently apply regulatory requirements and Pfizer policies.
Qualifications (i.e., preferred education, experience, attributes)
Minimum a bachelor’s degree in healthcare professional qualification (ie, Pharmacy, Dentistry, Nursing etc).
0–3-years’ experience in pharmacovigilance/ related domains.
Work Location Assignment: Hybrid
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Medical