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Drug Safety Associate

0-2 years
Not Disclosed
10 Sept. 3, 2025
Job Description
Job Type: Full Time Education: B.Sc/ M.Sc/ M.Pharm/ B.Pharm/ 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 Description – Associate, Pharmacovigilance Officer I

About Indegene

We are a technology-led healthcare solutions provider, driven by our purpose to enable healthcare organizations to be future-ready. At Indegene, we offer accelerated, global career opportunities for talent that is bold, industrious, and nimble.

With us, you will experience:

  • A unique career journey that celebrates entrepreneurship.

  • Growth at the exciting intersection of healthcare and technology.

  • Mentorship from some of the most brilliant minds in the industry.

  • A fast-track global career aligned with Indegene’s high-speed growth.

Our culture is shaped by passion, innovation, collaboration, and empathy. We are purpose-driven, customer-obsessed, bold in our actions, and nimble in our decision-making.

Explore more at: www.careers.indegene.com


Role: Associate – Pharmacovigilance Officer I

Key Responsibilities

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

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

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

  • Identify serious adverse events and special scenarios such as:

    • Lack of efficacy

    • Exposure and pregnancy cases

    • At-risk cases

    • Product quality complaints

  • Attach and review relevant source documents, safety information, queries, and follow-up data.

  • Facilitate follow-up based on queries from Data Entry, QC, or Medical Review teams.

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

  • Code suspect/co-suspect and concomitant products as per client conventions and regulatory requirements.

  • Draft case narratives as required.


Desired Profile

Must-Have Skills

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

  • Excellent cognitive abilities: verbal reasoning, attention to detail, analytical and critical thinking.

  • Good knowledge of medical terminology and therapy areas.

  • Strong comprehension and problem-solving skills.

  • Effective communication skills (verbal and written) in English.

  • Strong interpersonal skills.

Nice-to-Have

  • Exposure to global pharmacovigilance processes.

  • Familiarity with safety databases and regulatory guidelines.

  • Ability to work in a fast-paced, collaborative environment.


Why Join Us

  • Opportunity to grow with a global leader in healthcare technology.

  • Fast-track career progression with structured mentorship.

  • Be part of an inclusive and purpose-driven culture.


Opportunity Employer

Indegene is proud to be an Equal EmploEqualyment Opportunity (EEO) Employer. We are 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, gender identity, physical ability, disability, veteran status, or any other protected characteristic. All employment decisions are made based on business requirements, merit, and qualifications.


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