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.

Technical Skill Requirements

· Experience in pharmacovigilance, in clinical care, or in clinical or scientific research is an advantage but not a requirement.

· Demonstrated computer literacy, particularly in the use and management of relational databases.

· Ability to achieve personal objectives while meeting departmental standards of performance.

· Ability to work under supervision in a matrix organization.

· Excellent oral and written communication skills.

· Fluency in spoken and written English; knowledge of additional language(s) an advantage.

· Experience and skill with medical writing an advantage.

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

· Ability, with supervision, to solve routine problems and to surface issues constructively.

· Ability to make basic decisions with an understanding of the consequences.

· Bachelor’s degree in a science-related field, pharmacy, nursing, or equivalent; healthcare professional qualification preferred.

  
 

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Medical

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