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 prioritizationcriteria, and noting reasons for any delays.
• Assess cases to distinguish those with particular complexities and/or specific issues, andescalate 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

· 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.

  
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

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