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Drug Safety Associate

0-2 years
Not Disclosed
10 Sept. 16, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/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

Job Title: Drug Safety Associate

Date Posted: 22 Aug 2025
Location: Pune, MH, India


Company Overview:

Indegene is a technology-led healthcare solutions provider driven by the purpose of enabling healthcare organizations to be future-ready. We offer accelerated, global growth opportunities for talent that is bold, industrious, and nimble. At Indegene, you will gain a unique career experience guided by passion, innovation, collaboration, and empathy. Our global fast-track career programs allow you to grow alongside Indegene’s rapid expansion while being mentored by industry experts.


Job Summary:

As a Drug Safety Associate (Pharmacovigilance Officer I), you will be responsible for supporting the patient safety case-handling process, ensuring compliance with regulatory requirements, and maintaining high-quality safety data. You will work on adverse event (AE) and safety report processing, coding, follow-ups, and narrative drafting, contributing to overall drug safety monitoring and pharmacovigilance activities.


Key Responsibilities:

  • Confirm validity of safety cases by identifying minimum criteria for case creation.

  • Perform duplicate searches to create initial or follow-up cases.

  • Understand patient safety case-handling principles, concepts, and regulatory reporting requirements.

  • Identify serious adverse events (SAEs) and special scenario cases, including:

    • Lack of efficacy

    • Exposure and pregnancy cases

    • At-risk cases

    • Product quality complaint-only cases

  • Attach relevant source documents or safety information for each case.

  • Facilitate follow-ups based on queries from Data Entry/QC/Medical Review or missing/inconsistent information in source files.

  • Perform medical coding (Adverse Event, Medical History, Lab Data, Indications) using standardized terminology (e.g., MedDRA).

  • Code products (Suspect/Co-suspect, Concomitant) according to client conventions and regulatory requirements.

  • Draft case narratives accurately and in a timely manner.


Required Skills & Qualifications:

  • Understanding of case-handling principles and the overall drug research process.

  • Strong cognitive abilities including verbal reasoning, attention to detail, critical thinking, and analytical skills.

  • Knowledge of therapy areas and medical terminology.

  • Excellent comprehension skills.

  • Effective verbal and written communication skills with fluency in English.

  • Strong interpersonal skills.


Nice to Have (Optional):

  • Additional experience in pharmacovigilance processes, regulatory compliance, or life sciences domains.


Work Environment & Perks:

  • Opportunity to work in a fast-paced, innovative, and globally connected healthcare technology environment.

  • Exposure to pharmacovigilance operations across multiple therapeutic areas.

  • Collaborative and mentoring-driven work culture.


Equal Opportunity Employer:

Indegene is committed to inclusion and diversity. All employment decisions, from hiring to separation, are based on business requirements, candidate merit, and qualifications. We do not discriminate based on race, religion, sex, color, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristic.

All qualified applicants will receive consideration without regard to:

  • Race, color, religion, sex, national origin

  • Gender identity or sexual orientation

  • Disability status or protected veteran status