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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