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Syneos Health®, a global biopharmaceutical solutions organization, is hiring a Safety & Pharmacovigilance (PV) Coordinator for its Hyderabad office. This opportunity is ideal for B.Pharm or M.Pharm graduates with at least 1 year of experience in post-marketing safety (PMS) and spontaneous case processing.
If you are looking to build a strong career in Pharmacovigilance, Drug Safety Operations, and ICSR Processing, this role offers exposure to global safety databases, regulatory reporting, and compliance with ICH-GCP and GVP standards.
🔍 Key Job Details
- Position: Safety & PV Coordinator
- Company: Syneos Health
- Location: Hyderabad (also listed Pune)
- Employment Type: Full-time, Office-based
- Experience Required: Minimum 1 year
- Education: B.Pharm / M.Pharm only
🧾 Job Responsibilities
- Enter and track Individual Case Safety Reports (ICSRs) in PVG systems.
- Process ICSRs according to SOPs and project-specific safety plans.
- Triage cases and assess data for completeness, accuracy, and regulatory reportability.
- Code adverse events, medical history, concomitant medications, and tests using MedDRA.
- Prepare high-quality case narratives.
- Perform duplicate case detection and management.
- Conduct literature screening and safety review.
- Support xEVMPD product record validation and submission.
- Perform manual recoding of product and substance terms.
- Participate in SPOR/IDMP activities.
- Ensure documentation is filed in TMF and PV System Master File.
- Maintain compliance with ICH-GCP, GVP, and global PV regulations.
- Support audits and inspections.
🎓 Qualifications & Skills
- B.Pharm or M.Pharm degree (mandatory)
- 1+ year experience in PMS and spontaneous case processing
- Knowledge of LSMV or Argus safety database
- Strong understanding of clinical trial phases II–IV and post-marketing safety
- Familiarity with MedDRA coding and drug dictionaries
- Good communication and documentation skills
- Proficiency in MS Word, Excel, PowerPoint, Outlook
💼 Why Join Syneos Health?
- Work with a company supporting 94% of novel FDA-approved drugs
- Global exposure to clinical trials and post-marketing safety operations
- Strong learning & development programs
- Inclusive, employee-focused work culture
- Career progression in Pharmacovigilance & Drug Safety
💰 Estimated Salary (India)
₹4,50,000 – ₹7,50,000 per annum (based on experience and skills)
📌 How to Apply
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