💼 Job Title: Drug Safety Associate
📅 Date Posted: 5 September 2025
📍 Location: Bangalore, Karnataka, India
🏢 Company: Indegene
🌐 Careers Page: www.careers.indegene.com
🌟 About Indegene
Indegene is a technology-led healthcare solutions provider, empowering global healthcare organizations to be future-ready. With a strong focus on innovation, collaboration, and customer-centricity, Indegene offers an environment that fosters entrepreneurial thinking, fast growth, and global exposure.
We operate at the intersection of healthcare and technology, and are committed to transforming the healthcare ecosystem through bold, nimble, and industrious action.
🧠 About the Role: Drug Safety Associate (Pharmacovigilance Officer I)
As a Drug Safety Associate, you will be responsible for evaluating and processing individual case safety reports (ICSRs), ensuring compliance with global pharmacovigilance regulations. You will contribute to patient safety by identifying, coding, and reporting adverse events and other safety-related data.
This is an excellent opportunity for early-career professionals seeking to build a strong foundation in drug safety and pharmacovigilance within a fast-growing, global organization.
🔧 Key Responsibilities
Validate and confirm the minimum criteria for case creation.
Perform duplicate checks to determine if a case is initial or follow-up.
Identify and process serious adverse events (SAEs) and special case scenarios including:
Lack of efficacy
Pregnancy/exposure cases
At-risk populations
Product quality complaints
Code medical data using standard dictionaries such as MedDRA, including:
Adverse events
Medical history
Lab data
Indications
Code product information (suspect, concomitant, co-suspect) per client and regulatory standards.
Draft narratives for case documentation.
Attach relevant source documents and safety information to case files.
Facilitate follow-ups for missing or inconsistent information as needed.
Maintain compliance with regulatory reporting requirements for ICSRs.
🧾 Requirements
✅ Must-Have Qualifications & Skills
Understanding of pharmacovigilance principles, regulatory requirements, and the drug safety case-handling process.
Strong cognitive abilities:
Verbal reasoning
Attention to detail
Analytical and critical thinking
Proficiency in medical terminology and therapy areas.
Excellent comprehension and communication skills (verbal and written) in English.
Ability to work in a fast-paced, detail-oriented environment.
➕ Nice-to-Have
Prior experience or internship in pharmacovigilance or clinical research.
Familiarity with global regulatory systems and safety databases.
🎁 What We Offer
A global fast-track career with exposure to leading healthcare and pharmaceutical clients.
Mentorship from experienced professionals in the pharmacovigilance and life sciences industry.
Opportunities to work at the cutting-edge of healthcare and technology.
A collaborative and inclusive culture driven by purpose, passion, and performance.
💡 Equal Opportunity Employer
Indegene is an Equal Employment Opportunity Employer. We are committed to building a diverse and inclusive workplace. All employment decisions are made based on business needs, candidate qualifications, and merit.
We do not discriminate on the basis of race, religion, gender, sexual orientation, age, disability, nationality, or any other characteristic protected by law.
📩 Ready to Apply?
Explore career opportunities with us at www.careers.indegene.com. Join Indegene and start your journey toward a meaningful, global healthcare career today.
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