Syneos Health, a global leader in biopharmaceutical solutions, is hiring a Principal Safety & Pharmacovigilance (PV) Specialist – Literature Case Processing & Review for its India operations in Gurugram and Hyderabad. This is a senior-level pharmacovigilance role ideal for professionals with strong expertise in literature search, ICSR processing, safety reporting, and team leadership.
With Syneos Health having supported 94% of novel FDA-approved drugs, this role offers an opportunity to work at the forefront of global drug safety and regulatory compliance.
📝 Key Responsibilities
As a Principal Safety & PV Specialist, your core responsibilities will include:
- Conducting systematic and ad-hoc literature searches in Embase, PubMed, Medline for ICSR identification
- Creating, validating, and optimizing PV-specific search strategies
- Extracting and summarizing safety-relevant information from global and local literature
- Managing literature case processing (ICSRs) end-to-end
- Triage, data entry, MedDRA/WHO-DD coding, and narrative writing of ICSRs
- Ensuring regulatory-compliant expedited and periodic safety reporting
- Preparing and maintaining Safety Management Plans (SMPs)
- Coordinating workflow, work allocation, and program deliverables
- Supporting trend analysis, signal detection, and safety data reconciliation
- Acting as a Subject Matter Expert (SME) and mentoring team members
- Participating in audits, inspections, and investigator training
- Ensuring compliance with ICH-GCP, GVP, SOPs, and global regulations
🎓 Qualifications & Skills Required
To be eligible for this role, candidates must have:
🎓 Education
- B.Pharm / M.Pharm / PharmD / BDS / BMS
💼 Experience
- Minimum 8 years of experience in Literature Case Processing (PV)
- Proven team lead or mentoring experience in pharmacovigilance
🛠️ Technical & Professional Skills
- Strong knowledge of ICSR processing and safety databases
- In-depth understanding of clinical trials (Phase II–IV) & post-marketing safety
- Expertise in ICH-GCP, GVP, and global PV regulations
- Proficiency in MS Word, Excel, PowerPoint, Outlook, Visio
- Excellent communication, organizational, and decision-making skills
- High attention to detail with ability to meet tight deadlines
🎁 Benefits of Working at Syneos Health
- Career development and structured progression pathways
- Global exposure across clinical and post-marketing safety programs
- Supportive leadership and collaborative work culture
- Comprehensive training in therapeutic areas and PV systems
- Inclusive “Total Self” culture promoting diversity and well-being
📍 Job Location
- Gurugram, Haryana
- Hyderabad, Telangana
(Office-based role; minimal travel up to 10% may be required)
💰 Salary (Estimated)
- ₹18,00,000 – ₹30,00,000 per annum (INR)
(Salary may vary based on experience, skills, and internal benchmarks)
📨 How to Apply
