Global CRO leader Parexel is hiring Patient Safety Associate I across India. This is an excellent entry-level pharmacovigilance opportunity for Life Sciences and Pharmacy graduates looking to build a career in drug safety, ICSR processing, and regulatory compliance.
If you are seeking a Pharmacovigilance job in India with exposure to global safety databases, regulatory submissions, MedDRA coding, and compliance metrics, this role offers structured training and career growth.
📍 Job Locations
- Hyderabad
- Bengaluru
- Mohali
🔬 Key Responsibilities – Patient Safety Associate I
1️⃣ ICSR Processing & Case Management
- Monitoring incoming safety reports (EudraVigilance, literature, mailboxes)
- Data entry of valid cases into safety database
- MedDRA coding as per Points to Consider
- Causality, seriousness & expectedness assessment
- Preparing medically cohesive case narratives
- Query management and follow-up requests
- Compliance tracking for regulatory timelines
2️⃣ Safety Reporting & Submissions
- Submission of ICSRs to Health Authorities
- Support Periodic Safety Reports (PBRER/DSUR)
- Unblinding for safety reporting
- Portal/gateway regulatory setup
- Compliance metrics reconciliation
3️⃣ Literature Review & Signal Screening
- Literature search strategy development
- ADR identification & safety signal screening
- Peer review of literature abstracts
- Local journal monitoring
- Database thesauri updates
4️⃣ Regulatory Support
- Regulatory database management
- eCTD support activities
- SmPC validation
- xEVMPD submissions
- Risk Management Plan tracking
🎓 Eligibility Criteria
Education:
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- B.Pharm / M.Pharm
- Pharm.D
- Biotechnology
- Microbiology
- Biochemistry
- Biomedical Sciences
- Life Sciences degree
Skills Required:
- Basic pharmacovigilance knowledge
- Understanding of ICH Guidelines
- Familiarity with MedDRA coding
- MS Office proficiency
- Strong attention to detail
- Interest in drug safety & regulatory reporting
Freshers with strong pharmacovigilance training may apply.
💼 Why Join Parexel?
- Global CRO exposure
- Structured LMS training
- Audit & inspection readiness experience
- Regulatory submission learning
- Growth into Senior Drug Safety roles
- Work on global clinical development projects
Parexel emphasizes empathy-driven clinical research and global compliance standards.
💰 Salary (Estimated)
₹3.5 LPA – ₹5.5 LPA (Based on experience & location)
📩 How to Apply
📅 Application Deadline
