Are you a fresh graduate looking to kickstart your career in pharmacovigilance and drug safety? Navitas Life Sciences is hiring Trainee Drug Safety Associates to join their dynamic team. This is an excellent opportunity for freshers to gain hands-on experience in pharmacovigilance, case processing, and drug safety management.
📩 Send your resume to: roshini.m@navitaslifesciences.com
Job Description: Trainee Drug Safety Associate
Key Responsibilities:
- Perform data entry of Individual Case Safety Reports (ICSRs) into safety databases.
- Review and evaluate Adverse Event (AE) case information for accuracy and completeness.
- Ensure compliance with internal policies, global regulatory requirements (FDA, EMA, etc.), and project SLAs/KPIs.
- Code medical terms using standard dictionaries (MedDRA, WHO-DD, Company Product Dictionary).
- Prepare and review medically relevant safety narratives in chronological order.
- Conduct self-quality checks before case submission.
- Generate follow-up queries for incomplete case details.
- Address case corrections based on feedback from Quality/Medical reviewers.
- Maintain proper source document preparation and archival.
- Support team leads with operational and compliance-related tasks.
Eligibility & Skills Required:
- Fresh graduates (B.Pharm, M.Pharm, B.Sc/M.Sc in Life Sciences, Pharmacy, or related fields).
- Strong attention to detail and ability to follow SOPs (Standard Operating Procedures).
- Basic knowledge of pharmacovigilance, drug safety, and medical terminology.
- Familiarity with MedDRA coding is a plus.
- Good written and verbal communication skills.
- Ability to work in a fast-paced, deadline-driven environment.
About Navitas Life Sciences
Navitas Life Sciences is a leading global provider of pharmacovigilance, regulatory, and clinical research services. The company specializes in drug safety, risk management, and compliance solutions for pharmaceutical, biotech, and healthcare organizations.
✅ Why Join Navitas?
- Structured training & mentorship in pharmacovigilance.
- Exposure to global regulatory standards (FDA, EMA, ICH-GCP).
- Career growth opportunities in drug safety & pharmacovigilance.
- Collaborative and learning-focused work environment.
How to Apply?
If you are interested in this Trainee Drug Safety Associate role, send your updated resume to:
📧 Email: roshini.m@navitaslifesciences.com