The Senior Patient Safety Specialist will provide advanced support across global pharmacovigilance operations including clinical trial safety and post-marketing surveillance. The role involves leadership responsibilities, regulatory compliance oversight, case processing, safety reporting, and mentoring junior team members.
This pharmacovigilance job in Hyderabad offers exposure to global regulatory frameworks including EMA, FDA, and ICH guidelines.
Key Responsibilities
Pharmacovigilance & ICSR Management
- Lead safety case processing workflows and database setup
- Perform seriousness, causality, and expectedness assessments
- Review case narratives and reconciliation activities
- Generate safety reports and compliance metrics
- Conduct quality control for ICSRs and aggregate reports
Safety Reporting & Regulatory Submissions
- Handle global safety submissions to health authorities
- Manage gateway setup and regulatory reporting schedules
- Coordinate unblinding activities and product registrations
- Support audits, inspections, and quality improvement initiatives
Literature Review & Signal Detection
- Develop literature search strategies
- Screen publications for adverse drug reactions
- Support signal detection and medical review activities
- Ensure compliance with global literature monitoring regulations
Affiliate & Regulatory Intelligence Support
- Coordinate with global affiliates and local country offices
- Maintain regulatory intelligence databases
- Monitor global pharmacovigilance regulation updates
- Provide training and mentorship to junior staff
Required Qualifications
Educational Qualification
Candidates should possess any of the following:
- B.Pharm
- M.Pharm
- Pharm.D
- BSc Life Sciences
- MSc Life Sciences
- Nursing Degree
- Other healthcare-related qualifications
Experience
- Minimum 5+ years of pharmacovigilance experience
- Hands-on experience in:
- ICSR processing
- Regulatory reporting
- Safety databases
- Aggregate reports
- Literature surveillance
Required Skills
- Strong understanding of ICH guidelines
- Expertise in global pharmacovigilance regulations
- Knowledge of EMA, FDA, and international safety reporting standards
- Excellent analytical and communication skills
- Experience with safety databases and workflow management
- Team mentoring and project management capabilities
Why Join Parexel?
Benefits of Working at Parexel
- Opportunity to work with a globally recognized CRO
- Exposure to international pharmacovigilance projects
- Career growth in drug safety and regulatory affairs
- Collaborative and innovation-driven work culture
- Learning opportunities in global clinical development
Salary Expectations
The estimated salary for the Senior Patient Safety Specialist role at Parexel Hyderabad ranges between:
₹10 LPA – ₹18 LPA (Approx.)
Salary may vary depending on experience, technical expertise, and interview performance.
How to Apply
Application Link
