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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.02 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.02
* Bachelor’s degree in a science-related field, pharmacy, nursing, or
equivalent; healthcare professional qualification preferred.0202
Work Location Assignment:02On Premise
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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