💼 Syneos Health Hiring: Pharmacovigilance Safety & PV Specialist I | Gurgaon (Hybrid)
🏢 Company: Syneos Health📍 Location: Gurgaon, India (Hybrid)
🎓 Eligibility: B.Pharm / M.Pharm / Pharm.D / BDS / BMS / MBBS / Nursing / Life Sciences
🧪 Experience: 1 – 2.5 Years
💰 Salary: ₹7–12 LPA (Approx.)
📝 Job Type: Safety & PV Specialist I | Full-Time | Pharmacovigilance | Drug Safety
🔎 Verified: ✅ Verified Job via Medical Jobs India – hitechplus.in
📄 Job Overview
Syneos Health, a global leader in biopharmaceutical solutions, is seeking a Safety & PV Specialist I for their Gurugram office (Hybrid). This is an exciting opportunity for life sciences graduates, pharmacists, or nurses to grow their career in pharmacovigilance and drug safety. The role involves literature searches, ICSR management, regulatory compliance, and safety support across clinical trials and post-marketing programs.
🔬 Key Responsibilities
- ✔ Conduct systematic and ad-hoc literature searches in biomedical databases (Embase, PubMed, Medline).
- ✔ Extract, summarize, and validate key safety data from literature sources.
- ✔ Develop and validate search strategies for pharmacovigilance purposes.
- ✔ Conduct local literature searches as per global/local regulatory requirements.
- ✔ Enter and track ICSR data in PVG systems and ensure quality compliance.
- ✔ Triage, verify completeness and regulatory reportability of ICSRs.
- ✔ Perform MedDRA coding (events, history, medications) and prepare narrative summaries.
- ✔ Manage duplicates, SPOR/IDMP, and xEVMPD product record validation.
- ✔ Support timely submission of expedited safety reports per regulations.
- ✔ Maintain compliance with SOPs, GVP, ICH-GCP, and regulatory standards.
✅ Required Qualifications & Skills
- ✅ Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or related field.
- ✅ Strong knowledge of safety databases, medical terminology, and ICSR processing.
- ✅ Understanding of clinical trials (Phases II–IV) and post-marketing safety.
- ✅ Proficiency in MS Office, Outlook, Teams, and collaborative tools.
- ✅ Excellent written/verbal communication and organizational skills.
- ✅ Ability to work independently and collaboratively in a hybrid environment.
🎁 Benefits of Joining Syneos Health
- 🌍 Work with a global biopharmaceutical leader impacting patient safety worldwide.
- 📈 Continuous training and career development opportunities in PV.
- 🤝 Supportive “Total Self” culture promoting diversity and inclusion.
- 💼 Exposure to global clinical trials and post-marketing programs.
- 💰 Competitive compensation and hybrid work flexibility.
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📌 Note Before You Apply:
Update your CV to highlight ICSR processing, MedDRA coding, literature search skills, and regulatory compliance experience to increase selection chances.
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🟢 Verified Job via Medical Jobs India – hitechplus.in
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