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Safety Surveillance Associate

0-3 years
Not Disclosed
10 March 3, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Safety Surveillance Associate

Location: Chennai, India
Job Type: Full-time
Reports to: Case Processing Team Lead
Work Location Assignment: Hybrid

Position Purpose:

  • Review, prepare, and complete reports of adverse drug experiences to determine the safety profile of Pfizer’s products and 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.
  • Review case criteria to determine the appropriate workflow for case processing.
  • Write and edit case narratives.
  • Generate reports, ensuring adherence to regulatory compliance timelines.
  • Determine appropriate case follow-up, requesting follow-up letters when necessary.
  • 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 in Pfizer products, corporate and global regulations, guidelines, SOPs, writing practices, data entry conventions, and safety database search functions.
  • Consistently apply regulatory requirements and Pfizer policies.

Qualifications:

  • Minimum a bachelor’s degree in a healthcare-related field (Pharmacy, Dentistry, Nursing, etc.).
  • 0–3 years' experience in pharmacovigilance or related domains.