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Looking to start your career in pharmacovigilance? Parexel is hiring a Patient Safety Associate I in India. This is a high-growth opportunity for life sciences graduates to enter the drug safety and pharmacovigilance domain, working on ICSR processing, regulatory compliance, and safety reporting.
This role is ideal for candidates seeking entry-level pharmacovigilance jobs in India, especially those interested in clinical research, adverse event reporting, and global regulatory frameworks.
๐งพ Key Responsibilities
Pharmacovigilance & ICSR Processing
- Perform Individual Case Safety Report (ICSR) data entry and processing
- Monitor safety reports from sources like literature, EudraVigilance, and emails
- Conduct MedDRA coding and ensure case accuracy
- Prepare ADR narratives and case documentation
- Handle follow-ups, queries, and case reconciliation
Safety Reporting & Compliance
- Submit ICSRs to regulatory authorities within timelines
- Track compliance metrics and investigate late cases
- Support audits, inspections, and regulatory submissions
- Assist in aggregate reporting (PBRER, DSUR)
Literature Review & Signal Detection
- Perform literature searches for adverse drug reactions (ADRs)
- Screen abstracts and identify safety signals
- Maintain search strategies and local journal databases
Regulatory & Affiliate Support
- Assist in regulatory submissions and product registrations
- Coordinate with global affiliates for safety data exchange
- Support local compliance and reporting requirements
๐ Qualifications Required
- Educational Qualification:
- M.Sc (Life Sciences)
- M.Pharm / B.Pharm
- Pharm D
- BDS
- Graduation Year: 2023, 2024, 2025, 2026
๐ง Skills & Competencies
- Basic knowledge of pharmacovigilance and drug safety
- Understanding of ICH guidelines
- Strong attention to detail and analytical skills
- Good communication and documentation skills
- Familiarity with clinical databases and MS Office
๐ผ Salary & Benefits
- ๐ฐ Estimated Salary: โน3.5 โ โน5.5 LPA
- ๐ Global exposure in clinical research projects
- ๐ Strong career growth in pharmacovigilance
- ๐ Continuous learning via LMS and training modules
- ๐ค Opportunity to work with international clients
๐ Why Join Parexel?
Parexel is a globally recognized CRO offering end-to-end clinical development services. Employees gain hands-on exposure to global drug safety regulations, making it one of the best companies for pharmacovigilance jobs for freshers in India.
๐ฉ How to Apply
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