Drug Safety Associate
Location: Bengaluru, Karnataka, India
About Indegene:
We are a technology-led healthcare solutions provider, driven by our purpose to enable healthcare organizations to be future-ready. At Indegene, you gain a unique career experience that celebrates entrepreneurship and is guided by passion, innovation, collaboration, and empathy. Explore exciting opportunities at the convergence of healthcare and technology at Indegene Careers.
Why Join Us:
Kick-start your career with us! The first few years of your career lay the foundation for your professional journey. At Indegene, we promise a differentiated career experience, where you will work at the exciting intersection of healthcare and technology and be mentored by industry leaders. We offer a global fast-track career path with opportunities to grow alongside Indegene’s high-speed growth.
Our Values:
- Purpose-driven: Enabling healthcare organizations to be future-ready.
- Customer obsession: Ensuring our customers achieve their goals.
- Bold, nimble, and industrious: Taking bold actions, making quick decisions, and working diligently.
Role and Responsibilities:
- Confirm case validity by identifying minimum criteria for case creation.
- Perform duplicate searches to create initial or follow-up cases.
- Understand principles and concepts of patient safety case handling, including regulatory requirements.
- Identify serious adverse events and special scenarios, including lack of efficacy, exposure, pregnancy, at-risk cases, and product quality complaints.
- Attach relevant source documents or any safety information/queries/follow-up information.
- Facilitate follow-up based on queries or inconsistencies in the source file.
- Perform coding for adverse events, medical history, lab data, indications, etc., using standardized medical coding dictionaries like MedDRA.
- Code products (suspect/co-suspect, concomitant) as per client conventions and regulatory requirements.
- Draft narratives.
Requirements:
- Understanding of case-handling processes and overall drug research processes.
- Cognitive abilities including verbal reasoning, attention to detail, and critical and analytical thinking.
- Good knowledge of therapy areas and medical terminology.
- Strong comprehension skills.
- Excellent communication skills (verbal and written) with fluency in English.
- Interpersonal skills.
- Immediate joiners only.
Equal Opportunity Employer:
Indegene is committed to inclusion and diversity. We do not discriminate based on race, religion, sex, color, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristic. Employment decisions are based on business requirements, merit, and qualifications.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristic.