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 and Japanese; 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: On Premise
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Medical
#LI-PFE