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Parexel is actively hiring for the role of Patient Safety Associate II across India (Mohali & Hyderabad). This is an excellent opportunity for professionals with 2+ years of pharmacovigilance experience looking to advance their careers in drug safety, ICSR processing, and regulatory reporting.
As a global leader in clinical research and pharmacovigilance services, Parexel offers exposure to clinical trials, post-marketing surveillance, and global safety operations, making this role ideal for candidates seeking growth in pharmacovigilance jobs in India.
Key Responsibilities โ Patient Safety Associate II
1. ICSR Processing & Case Management
- Perform Individual Case Safety Report (ICSR) processing
- Data entry, validation, and MedDRA coding
- Prepare case narratives and ensure medical accuracy
- Conduct follow-ups and query management
- Perform reconciliation and quality checks
2. Safety Reporting & Submissions
- Support regulatory safety submissions (global and local)
- Ensure compliance with reporting timelines
- Perform quality control on case listings
- Assist in aggregate reporting and submission tracking
3. Literature Surveillance
- Conduct literature search and review for adverse drug reactions
- Screen scientific publications for safety signals
- Upload and manage articles in safety databases
- Support database thesauri updates
4. Affiliate & Regulatory Support
- Coordinate with global and local affiliates
- Support regulatory intelligence and compliance
- Assist with product registration and reporting rules
- Maintain safety databases and documentation
5. General Pharmacovigilance Activities
- Support audits and inspections
- Ensure adherence to ICH guidelines and PV regulations
- Assist in process improvement initiatives
- Mentor junior team members (as applicable)
Eligibility Criteria & Qualifications
Educational Qualification
- Degree in Life Sciences / Pharmacy / Biotechnology / Microbiology / Biochemistry / Healthcare
- Equivalent biomedical qualification accepted
Experience Required
- Minimum 2 years of pharmacovigilance experience
- Hands-on experience in:
- ICSR processing
- Safety databases
- Regulatory reporting
Required Skills
- Strong knowledge of pharmacovigilance processes
- Familiarity with ICH guidelines and global safety regulations
- Good understanding of medical terminology
- Analytical thinking and problem-solving ability
- Proficiency in MS Office and PV systems
Salary & Benefits
- Estimated Salary Range: โน4.5 LPA โ โน8.5 LPA
- Exposure to global pharmacovigilance projects
- Career growth in drug safety and regulatory affairs
- Opportunity to work with international clients
- Training and skill development programs
Job Location
- Mohali, India
- Hyderabad (Mindspace 20), India
How to Apply
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