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Associate Safety Data Management Specialist

Pfizer
Pfizer
0-2 years
Not Disclosed
Chennai, India
10 March 24, 2026
Job Description
Job Type: Full Time Hybrid Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

Associate Safety Data Management Specialist

Location: Chennai
Job Type: Full-Time | Hybrid
Experience Required: 0–2 years
Job ID: 4953942

Overview
Join Pfizer as an Associate Safety Data Management Specialist and contribute to advancing global patient safety. This role sits within the Worldwide Medical and Safety team, focusing on pharmacovigilance operations and safety data management. You will play a critical role in monitoring, evaluating, and processing safety data to ensure the safe and appropriate use of medicines across global markets.

Key Responsibilities
Support pharmacovigilance activities by monitoring safety data related to drugs, biologics, and medical devices
Intake, evaluate, and process adverse event reports from clinical trials and post-marketing sources
Perform end-to-end processing of Individual Case Safety Reports (ICSRs) within the ARGUS Safety database
Conduct case validation, duplicate checks, prioritization, and data entry in compliance with global regulatory standards
Code adverse events and products using standard dictionaries and perform causality and listedness assessments
Draft and review case narratives ensuring accuracy, completeness, and regulatory compliance
Determine appropriate case follow-up actions and maintain data quality standards
Analyze post-marketing safety data and review medical literature to support regulatory and safety strategies
Collaborate with cross-functional teams to ensure timely and accurate safety reporting
Ensure adherence to internal SOPs, corporate policies, and global pharmacovigilance regulations

Required Skills and Competencies
Strong analytical and problem-solving skills
High attention to detail and data accuracy
Effective written and verbal communication skills
Ability to work in a structured, process-driven environment
Collaborative mindset with the ability to work in cross-functional teams
Commitment to continuous learning and professional development

Eligibility Criteria
Bachelor’s or Master’s degree in Pharmacy (B.Pharm, M.Pharm, or Pharm.D)
0–2 years of experience in pharmacovigilance, drug safety, or related domain

Preferred Qualifications
Certification or training in pharmacovigilance or drug safety
Understanding of global regulatory requirements and medical terminology
Familiarity with safety databases such as ARGUS
Exposure to AI tools such as ChatGPT or Microsoft Copilot for productivity enhancement
Research publications in peer-reviewed journals are an added advantage

About the Company
Pfizer is a leading biopharmaceutical organization dedicated to discovering, developing, and delivering innovative medicines and vaccines. With a strong commitment to science and patient care, Pfizer empowers healthcare decisions through evidence-based medical insights and global safety monitoring systems.

Why Apply
Opportunity to work with a global leader in pharmacovigilance and drug safety
Hands-on experience with advanced safety databases and global regulatory frameworks
Exposure to end-to-end ICSR processing and safety data management
Structured learning environment with strong career growth potential

Work Environment
This is a hybrid role based in Chennai, offering a balance of on-site collaboration and remote work flexibility.