Syneos Health is recruiting for the Drug Safety Specialist I / II position in Gurugram and Hyderabad. The role focuses on Individual Case Safety Report (ICSR) processing, pharmacovigilance, medical narrative writing, regulatory compliance, and quality checks.
Candidates with relevant qualifications and skills in drug safety and pharmacovigilance can explore this full-time, permanent opportunity.
Job Details
| Particulars | Details |
|---|---|
| Company | Syneos Health |
| Job Role | Drug Safety Specialist I / II |
| Locations | Gurugram and Hyderabad |
| Experience | 1–6 years |
| Employment Type | Full-time, Permanent |
| Department | Healthcare & Life Sciences |
| Role Category | Health Informatics |
| Industry | Clinical Research / Contract Research |
Responsibilities
- Perform end-to-end ICSR processing for spontaneous, clinical trial, and literature cases.
- Execute accurate data entry activities.
- Manage case workflows, including triage, coding, narrative writing, and submission readiness.
- Ensure compliance with global pharmacovigilance guidelines, SOPs, and regulatory requirements.
- Conduct quality checks on processed cases based on experience and performance.
Eligibility and Qualifications
Undergraduate qualifications:
- BDS – Bachelor of Dental Surgery
- B.Pharm – Pharmaceutical Analysis and Quality Assurance
- BHMS – Bachelor of Homeopathic Medicine and Surgery
Postgraduate qualifications:
- MDS – Dentistry
- M.Pharm – Pharmacy
Required Skills
- Drug Safety
- Pharmacovigilance
- ICSR Case Processing
- Clinical Trial Safety Cases
- Literature Case Processing
- Medical Narrative Writing
- Data Entry and Case Triage
- Safety Data Coding
- Quality Checks and Regulatory Compliance
