safety surveillance AssociatePfizer

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.
PrimaryResponsibilities
· 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 issuesconstructively.
· Ability to make basic decisions with an understanding of theconsequences.
· 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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Pfizer

Makati City, Metro Manila
Permanent
Full-time