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Associate Safety Data Management Specialist

Pfizer
Pfizer
0-5 years
Not Disclosed
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.