Global CRO leader Parexel is inviting applications for the position of Patient Safety Specialist at its Hyderabad, India location. This pharmacovigilance job offers hands-on exposure in ICSR processing, regulatory reporting, safety submissions, literature review, affiliate services, and regulatory intelligence.
If you are looking to build a long-term career in drug safety, pharmacovigilance operations, and global regulatory compliance, this opportunity provides strong learning exposure within global safety systems aligned with EMA, FDA, and ICH guidelines.
🔎 Job Overview
- Role: Patient Safety Specialist
- Location: Hyderabad, India
- Department: Pharmacovigilance / PV Operations
- Employment Type: Full-Time
- Industry: Clinical Research / Drug Safety / Regulatory Affairs
This role supports global patient safety operations including ICSR case management, safety submissions, regulatory intelligence, literature screening, and affiliate coordination.
🧪 Key Responsibilities
1️⃣ ICSR Processing & Case Management
- Execute Individual Case Safety Report (ICSR) workflows
- Prepare case narratives and perform quality control
- Generate routine safety listings and reports
- Ensure compliance with global reporting timelines
- Perform MedDRA coding support and PPQC activities
2️⃣ Safety Submissions
- Submit ICSRs and periodic safety reports to global health authorities
- Support portal/gateway setup and authority registrations
- Follow aggregate reporting schedules and unblinding procedures
- Monitor compliance metrics and quality improvements
3️⃣ Literature Search & Review
- Conduct structured literature searches
- Screen publications for adverse drug reactions
- Identify potential safety signals
- Ensure alignment with global pharmacovigilance regulations (EMA, FDA, ICH)
4️⃣ Affiliate & Regulatory Support
- Coordinate safety information exchange with affiliates
- Support local health authority requirements
- Maintain product safety databases and reporting rules
- Assist with regulatory impact assessments and data reconciliation
5️⃣ Regulatory Intelligence
- Monitor global drug/device safety reporting updates
- Disseminate regulatory alerts and summaries
- Maintain centralized regulatory intelligence repository
- Support SOP development and audit preparation
🎓 Eligibility Criteria
Education
- Degree in Pharmacy (B.Pharm/M.Pharm)
- Nursing
- Life Sciences
- Or other health-related discipline
Experience
- Experience in safety case management and regulatory reporting preferred
- Knowledge of ICH guidelines and global pharmacovigilance regulations
- Basic experience in safety databases (Argus/ArisG or similar) desirable
💡 Required Skills
- Strong understanding of pharmacovigilance processes
- Good analytical and problem-solving skills
- Knowledge of ICSR processing and safety submissions
- Familiarity with global PV regulations (FDA, EMA, ICH)
- Effective communication and time management
- Experience in pharmaceutical or CRO environment preferred
💰 Salary (Estimated)
Based on industry standards in Hyderabad:
- ₹4.5 LPA – ₹8.5 LPA (Depending on experience and PV exposure)
🌍 Why Choose Parexel?
Parexel is a globally recognized Clinical Research Organization (CRO) providing clinical, regulatory, consulting, and market access solutions. Working here offers:
- Global pharmacovigilance exposure
- Cross-functional collaboration
- Strong learning in safety compliance & regulatory systems
- Career growth in PV operations & drug safety
📌 How to Apply
