Associate Safety Data Management Specialist

0-5 years

Not Disclosed

Chennai

10 May 10, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Associate Safety Data Management Specialist

Company: Pfizer

Experience: Fresher

Location: Chennai

Job Responsibilities:

Carry out case processing activities.
Review, rank, verify, process, and document case-related information, including event terms, validity, seriousness, timelines, accuracy, and consistency. Process cases based on these assessments.
Review case criteria to determine appropriate workflow for case processing.
Assess cases to identify complexities or specific issues and escalate them appropriately.
Write and edit case narratives.
Determine and perform appropriate case follow-up, including generating follow-up requests.
Review processed cases to verify accuracy, consistency, and compliance with process requirements.
Liaise with key partners locally and other stakeholders regarding safety data collection and data reconciliation.
Develop and maintain expertise and knowledge of applicable corporate and global regulations, guidelines, Standard Operating Procedures (SOPs), data entry conventions, and search functions in the safety database.
Determine the reportability of scheduled reports, ensuring adherence to regulatory requirements.
Consistently apply regulatory requirements and Pfizer policies.
Participate in local, internal, and external safety activities.

Qualification & Experience:

Top 10 graduating students of Pharm. D or M. Pharm (Pharmacovigilance/Pharmacology/Pharmacy Practice) or B. Pharm.
Prefer students graduating in 2024 over 2023 graduates. Consideration of 2023 graduates is possible if provisional certificates are not received before Jun 2024.
Students should have at least one publication in a peer-reviewed journal.

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.

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Associate Safety Data Management Specialist

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