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Looking to start your career in pharmacovigilance and drug safety? Parexel is hiring a Patient Safety Associate I in Mohali, India. This is an excellent opportunity for freshers and early-career professionals to build expertise in ICSR processing, safety reporting, MedDRA coding, and regulatory compliance.
At Parexel, youโll contribute directly to improving global patient health by supporting clinical trials, safety monitoring, and regulatory processes.
๐ Key Responsibilities
1. Pharmacovigilance & ICSR Processing
- Monitor and triage safety reports (mailbox, literature, EudraVigilance)
- Perform ICSR data entry, case creation, and workflow management
- Conduct MedDRA coding and ensure case accuracy
- Prepare ADR forms and medically coherent narratives
- Perform follow-ups and query management
- Execute quality checks and validation of case data
2. Safety Reporting & Compliance
- Submit ICSRs to regulatory authorities and stakeholders
- Ensure compliance with global reporting timelines
- Handle late case investigations and compliance metrics
- Support expedited reporting procedures
- Maintain safety documentation and audit readiness
3. Literature Review & Signal Detection
- Conduct literature searches using defined strategies
- Identify adverse drug reactions (ADRs) and safety signals
- Perform peer review of literature screening results
- Maintain local journal databases and search strategies
4. Regulatory & Affiliate Support
- Assist in global regulatory submissions (eCTD, PBRER, RMP)
- Support product registrations and lifecycle management
- Coordinate with global affiliates for safety data exchange
- Maintain regulatory intelligence databases and trackers
5. General & Operational Tasks
- Follow SOPs and project workflows
- Participate in audits, training, and LMS modules
- Support client communication and project activities
- Maintain accurate timesheets and documentation
๐ Eligibility Criteria
- Qualification:
M.Pharm / B.Pharm / MSc (Life Sciences, Microbiology, Biotechnology, Biochemistry) - Skills Required:
- Basic knowledge of pharmacovigilance & ICH guidelines
- Understanding of ICSR workflow & drug safety processes
- Good communication and analytical skills
- Familiarity with MS Office and safety databases
- Experience:
Freshers or candidates with healthcare/PV exposure preferred
๐ผ Salary & Benefits (Estimated)
- Salary Range: โน3.5 LPA โ โน6 LPA
- Global exposure to clinical trials & safety operations
- Training in MedDRA, ICSR processing, and regulatory reporting
- Career growth in pharmacovigilance, drug safety, and clinical research
- Work with international clients and regulatory frameworks
๐ Why Join Parexel?
- Work with a leading global CRO
- Hands-on exposure to end-to-end pharmacovigilance
- Strong learning ecosystem with structured training programs
- Opportunity to transition into roles like:
- Drug Safety Associate
- Safety Scientist
- PV Quality / Signal Detection Specialist
๐ฉ How to Apply
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