Safety Surveillance Associate Job at Pfizer (Makati City)

Job Description

You will be relied on by the company to monitor its drug, biologics and medical devices surveillance program. This will include intake, evaluation and processing of the adverse reports received. You will support the clinical trial as well as the post marketing activities.

Job Responsibility

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 and perform appropriate case follow-up, generating and requesting follow-up letters
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 assigned products within a therapeutic area
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

Requirements

Bachelor's degree in a science-related field, pharmacy, nursing, or equivalent
healthcare Professional qualification required
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
Ability, with supervision, to solve routine problems and to surface issues constructively
Ability to make basic decisions with an understanding of the consequences

Nice to have

Experience in pharmacovigilance, in clinical care, or in clinical or scientific research
knowledge of additional language(s)
Experience and skill with medical writing

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Safety Surveillance Associate

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