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Pfizer
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Safety Surveillance Associate

Safety Surveillance Associate

Pfizer

2 - 5 years

1 - 5 Lacs

Chennai

Posted:2 days ago| Platform:

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Skills Required

Nursing Pharmacy Standard operating procedures clinical development Data collection Healthcare Workflow Pharmacovigilance Case processing Data entry

Work Mode

Work from Office

Job Type

Full Time

Job Description

About the job

Use Your Power for Purpose
At Pfizer, our Worldwide Medical and Safety colleagues are pivotal in bridging evidence-based medical decision support with stakeholders to enhance health and treatment outcomes. Whether you are developing frameworks to ensure our evidence is scientifically robust, offering unbiased and medically essential expertise, or exploring ways to address data gaps, our mission remains clear: to empower healthcare decisions regarding the safe and appropriate use of medicines for patients. Organizational Relationship(s) including to whom the position reports to:
Case Processing Team Lead 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.

Qualifications (i. e. , Preferred Education, Experience, Attributes)
Minimum a bachelor s degree in healthcare professional qualification (ie, Pharmacy, Dentistry, Nursing etc). 1 3-years experience in pharmacovigilance/ related domains. Work Location Assignment: Hybrid

Medical

#LI-PFE

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Safety Surveillance Associate