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Junior Drug Safety Associate

0-2 years
Not Disclosed
10 Sept. 18, 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, Karnataka, India


About the Company

Indegene is a technology-led healthcare solutions provider with a mission to enable healthcare organizations to be future-ready. We offer global career growth opportunities for bold, industrious, and nimble talent.

At Indegene, you will:

  • Work at the unique intersection of healthcare and technology.

  • Be mentored by industry experts.

  • Gain exposure to a global fast-track career.

  • Thrive in a culture driven by innovation, collaboration, empathy, and customer obsession.

For more opportunities, visit: www.careers.indegene.com


Position: Associate – Pharmacovigilance Officer I

Key Responsibilities

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

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

  • Apply principles of patient safety case-handling, including regulatory requirements for Individual Case Safety Reports (ICSRs).

  • Identify and classify serious adverse events (SAEs) and special scenarios such as lack of efficacy, pregnancy cases, at-risk cases, and product quality complaints.

  • Attach relevant source documents, queries, or follow-up details to cases.

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

  • Perform medical coding of adverse events, medical history, lab data, and indications using standardized dictionaries (e.g., MedDRA).

  • Code products (suspect, co-suspect, concomitant) in compliance with client and regulatory requirements.

  • Draft clear, accurate, and concise case narratives.


Required Qualifications & Skills

Must Have:

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

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

  • Good knowledge of therapy areas and medical terminology.

  • Strong comprehension, verbal, and written communication skills in English.

  • Good interpersonal skills.

Nice to Have:

  • Additional exposure to pharmacovigilance workflows.

  • Familiarity with regulatory reporting requirements.


Perks & Benefits

  • Mentorship and career growth opportunities.

  • Global exposure in a high-speed growth organization.

  • Work in a purpose-driven, innovative environment.


Equal Opportunity Statement

Indegene is proud to be an Equal Employment Employer and is committed to fostering a culture of inclusion and diversity.

We do not discriminate on the basis of race, religion, sex, color, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristic. Employment decisions are based on business requirements, merit, and qualifications.

All qualified applicants will receive consideration without regard to race, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristic.