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Drug Safety Associate (Pharmacovigilance Officer I)

2+ years
Not Disclosed
10 Sept. 2, 2025
Job Description
Job Type: Full Time Education: Not specified 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 (Pharmacovigilance Officer I)

Date Posted: 29 August 2025
Location: Bangalore, Karnataka, India


About Indegene

Indegene is a technology-led healthcare solutions provider, enabling healthcare organizations to become future-ready. We operate at the intersection of healthcare and technology, driven by innovation, collaboration, empathy, and a passion for making a difference.

At Indegene, we offer a global, fast-track career path with opportunities to work with some of the most brilliant minds in the industry. We celebrate entrepreneurship and empower talent to grow with our high-speed trajectory.

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


Role Overview

As a Drug Safety Associate (Pharmacovigilance Officer I), you will be part of the Pharmacovigilance team responsible for handling safety data and reporting to ensure compliance with global regulatory standards.


Key Responsibilities

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

  • Perform duplicate checks to determine if the case is an initial or follow-up.

  • Apply principles of patient safety and understand global regulatory reporting requirements for Individual Case Safety Reports (ICSRs).

  • Identify serious adverse events (SAEs) and special scenarios such as:

    • Lack of efficacy

    • Exposure during pregnancy

    • At-risk cases

    • Product quality complaints

  • Attach relevant source documents and follow-up information to cases.

  • Coordinate follow-up based on data entry/QC/medical review queries or missing/inconsistent source information.

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

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

  • Draft high-quality narrative summaries for case reporting.


Candidate Profile

Must Have:

  • Knowledge of case-handling procedures and the overall drug research process.

  • Familiarity with pharmacovigilance regulatory requirements.

  • Strong cognitive abilities including:

    • Verbal reasoning

    • Attention to detail

    • Analytical and critical thinking

  • Sound understanding of medical terminology and therapeutic areas.

  • Good comprehension skills.

  • Effective verbal and written communication skills in English.

  • Strong interpersonal abilities.

Nice to Have:

  • Exposure to pharmacovigilance tools or databases.

  • Previous experience in drug safety or life sciences domain.


Perks and Benefits

  • Accelerated career growth in a fast-paced, high-impact environment.

  • Mentorship from industry experts.

  • Opportunities to work at the global intersection of healthcare and technology.


Equal Opportunity Statement

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

All employment decisions—from hiring to separation—are based on business requirements, merit, and qualifications, without regard to race, religion, sex, color, age, national origin, pregnancy, sexual orientation, gender identity, disability status, veteran status, or any other legally protected characteristics.