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Associate Safety Data Management Specialist

1-2 years
Not Disclosed
10 July 24, 2025
Job Description
Job Type: Hybrid 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

 

Associate Safety Data Management Specialist – Chennai

Location: Chennai, India
Work Mode: Hybrid (Full-time)
Salary/Compensation: Not specified in the job description


Job Summary

Pfizer is hiring an Associate Safety Data Management Specialist to manage Individual Case Safety Reports (ICSRs) from clinical trials and post-marketing sources. The role involves working with the ARGUS safety database, performing causality and seriousness assessments, coding, and ensuring compliance with global pharmacovigilance regulations. This is a key role for professionals aiming to build expertise in drug safety and case processing.


Key Responsibilities

  • Process ICSRs, including validity checks, duplicate detection, case creation, and prioritization.

  • Code adverse events, assess seriousness, causality, and listedness.

  • Draft case narratives and determine appropriate follow-up actions.

  • Review processed cases to ensure accuracy and compliance with company and regulatory standards.

  • Handle XML source documents (E2B R2 and R3) and update the ARGUS safety database.

  • Collaborate with cross-functional teams to ensure timely case submissions.

  • Maintain thorough knowledge of global regulatory requirements and pharmacovigilance practices.


Required Skills & Qualifications

  • B. Pharm, M. Pharm, or Pharm. D (mandatory).

  • 1–2 years of experience in end-to-end ICSR processing.

  • Knowledge of medical terminology and global drug safety regulations.

  • Strong analytical, communication, and documentation skills.

  • Attention to detail and ability to work collaboratively in a fast-paced environment.

  • Continuous learning mindset and adaptability.


Preferred Qualifications

  • Hands-on experience with the ARGUS safety database.

  • Proficiency in XML source document processing (E2B R2/R3).

  • Certification in pharmacovigilance or related publications.


Perks & Benefits

  • Work with a global leader in pharmaceutical innovation.

  • Hybrid work model with career growth opportunities.

  • Exposure to advanced pharmacovigilance tools and international projects.

  • Competitive benefits package (as per company policy).


Company Description

Pfizer is one of the world’s premier biopharmaceutical companies, known for driving healthcare innovation. With a strong focus on patient safety, Pfizer’s pharmacovigilance team ensures high-quality data analysis and compliance with regulatory requirements across global markets.


Work Mode: Hybrid (Chennai, India)


Call-to-Action

Are you passionate about drug safety and pharmacovigilance? Apply now for the Associate Safety Data Management Specialist role at Pfizer and advance your career with a global healthcare leader.