Syneos Health®, a globally recognized biopharmaceutical solutions organization, is hiring a Safety & Pharmacovigilance Specialist I (Literature Review) for its India operations. This is a full-time, office-based role available in Gurugram, Hyderabad, and Pune. The position is ideal for pharmacovigilance professionals with hands-on experience in literature review, ICSR processing, and clinical trial safety.
With Syneos Health supporting over 94% of FDA-approved novel drugs and 95% of EMA-authorized products, this opportunity offers exposure to global safety operations, regulatory compliance, and career growth in drug safety and pharmacovigilance.
Key Responsibilities – Safety & PV Specialist I
As a Safety & PV Specialist (Literature Review), your responsibilities will include:
- Literature screening and review for pharmacovigilance case identification
- Processing and triaging Individual Case Safety Reports (ICSRs)
- Data entry and case management in safety databases
- MedDRA coding for adverse events, medical history, and indications
- Drug coding and maintenance of drug dictionaries
- Compilation of high-quality safety narratives
- Identification and management of duplicate ICSRs
- Manual recoding of product and substance terms
- Validation and submission of xEVMPD product records
- Activities related to SPOR / IDMP compliance
- Quality review of ICSRs and safety documentation
- Submission of safety documents to TMF and PSMF
- Support for audits and inspections
- Ensuring compliance with ICH-GCP, GVP, SOPs, and global safety regulations
Qualifications & Eligibility Criteria
To apply for this Safety & PV Specialist I role, candidates should meet the following criteria:
- Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or equivalent
- Minimum 2+ years of experience in literature review (pharmacovigilance)
- Preferred: Experience in literature case processing and clinical trial case processing
- Familiarity with Drug Safety Triage databases
- Strong knowledge of medical terminology and safety databases
- Understanding of clinical trial phases II–IV and post-marketing safety
- Knowledge of ICH-GCP, GVP, and global PV regulations
- Proficiency in MS Word, Excel, PowerPoint, Outlook, and shared platforms
- Strong attention to detail, communication, and time management skills
Why Join Syneos Health?
- Work with a global leader in clinical development and pharmacovigilance
- Structured career development and training programs
- Exposure to global regulatory and safety reporting standards
- Inclusive “Total Self” culture promoting diversity and belonging
- Competitive compensation and benefits
- Opportunity to work on high-impact global drug development programs
Salary Range (Indicative)
₹6,00,000 – ₹9,00,000 per annum (CTC)
Salary may vary based on experience, skills, and location.
Job Locations
- Gurugram, Haryana
- Hyderabad, Telangana
- Pune, Maharashtra
How to Apply
