job title: safety surveillance associate(pfizer)

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.