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Junior 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: Junior Drug Safety Associate

Date Posted: 2 Sept 2025
Location: Bangalore, KA, India


Company Overview:

Indegene is a technology-led healthcare solutions provider focused on enabling healthcare organizations to be future-ready. We offer accelerated global growth opportunities for talent that is bold, industrious, and nimble. At Indegene, employees gain a unique career experience that celebrates entrepreneurship and is guided by passion, innovation, collaboration, and empathy.

The company provides global fast-track career opportunities, mentorship from industry experts, and exposure to the convergence of healthcare and technology.


Job Summary:

As a Junior Drug Safety Associate (Pharmacovigilance Officer I), you will support pharmacovigilance operations by processing, coding, and reviewing safety cases, ensuring compliance with regulatory requirements, and assisting in the preparation of safety narratives. This role will help you develop expertise in patient safety case-handling and overall drug research processes.


Key Responsibilities:

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

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

  • Understand and apply principles of patient safety case-handling, including regulatory reporting requirements for individual case safety reports (ICSRs).

  • 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, Quality Control (QC), or Medical Review (MR) regarding missing or inconsistent information.

  • Perform medical coding (Adverse Events, Medical History, Lab Data, Indications) using standardized medical coding dictionaries, such as MedDRA.

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

  • Draft case narratives in accordance with established guidelines.


Required Skills & Qualifications:

  • Understanding of case-handling principles and 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.

  • Good comprehension and problem-solving skills.

  • Effective verbal and written communication skills in English.

  • Strong interpersonal skills.


Nice to Have (Optional):

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


Work Environment & Perks:

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

  • Exposure to pharmacovigilance operations across multiple therapeutic areas.

  • Collaborative work culture with mentoring opportunities.


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.

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