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Junior Drug Safety Associate

2+ years
not specified
10 Sept. 8, 2025
Job Description
Job Type: Full Time Education: Strong understanding of pharmacovigilance and case-handling processes Knowledge of drug safety and the broader drug research process Excellent attention to detail and verbal reasoning skills Strong 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 September 2025
Location: Bangalore, Karnataka, India
Company: Indegene


About Indegene:

Indegene is a technology-led healthcare solutions provider driven by the purpose of enabling healthcare organizations to be future-ready. We offer global growth opportunities for talent that is bold, industrious, and nimble.

At Indegene, you will:

  • Work at the exciting intersection of healthcare and technology

  • Be mentored by top industry professionals

  • Experience a differentiated, fast-track career path

To explore more opportunities, visit: www.careers.indegene.com


Position Overview:

As a Junior Drug Safety Associate (Associate - Pharmacovigilance Officer I), you will be responsible for processing and managing safety data related to pharmaceutical products in compliance with regulatory and client requirements.


Key Responsibilities:

  • Validate case information by confirming minimum criteria for case creation

  • Perform duplicate search and differentiate between initial and follow-up cases

  • Understand and apply principles of patient safety and case-handling processes

  • Identify serious adverse events (SAEs) and special scenarios (e.g., pregnancy, lack of efficacy, product quality complaints)

  • Attach relevant source documents and safety information to the case files

  • Conduct follow-up activities based on missing or inconsistent data

  • Code medical information such as:

    • Adverse events

    • Medical history

    • Laboratory data

    • Indications using standard coding dictionaries like MedDRA

  • Code suspect and concomitant products per client conventions and regulatory requirements

  • Draft case narratives accurately and concisely


Must-Have Qualifications:

  • Strong understanding of pharmacovigilance and case-handling processes

  • Knowledge of drug safety and the broader drug research process

  • Excellent attention to detail and verbal reasoning skills

  • Strong critical thinking and analytical abilities

  • Good knowledge of medical terminology and therapy areas

  • Good comprehension and English communication skills (both written and verbal)


Nice-to-Have Qualifications:

  • Prior experience in pharmacovigilance or related healthcare/clinical field

  • Familiarity with global regulatory requirements

  • Exposure to safety databases and tools


Perks and Benefits:

(Not specified — standard company benefits apply)


Equal Opportunity Statement:

Indegene is proud to be an Equal Employment Opportunity (EEO) employer and is committed to a culture of inclusion and diversity.

We do not discriminate on the basis of:

  • Race, religion, sex, colour, age, national origin, pregnancy, sexual orientation, gender identity, physical ability, or veteran status

All employment decisions are based on business needs, merit, and qualifications.