Safety & PV Coordinator
📄 About the Company
Syneos Health® is a global biopharmaceutical solutions organization supporting 94% of FDA-approved novel drugs.
The company delivers integrated services across clinical development, post-marketing safety, regulatory, and commercial operations with a strong focus on patient safety and compliance.
📌 Job Overview
Syneos Health is hiring a Safety & Pharmacovigilance (PV) Coordinator for its Hyderabad office (also listed for Pune).
This role is ideal for B.Pharm / M.Pharm professionals with minimum 1 year of experience in post-marketing safety (PMS) and spontaneous case processing.
You will work on global safety databases, ICSR processing, regulatory reporting, and compliance in a structured, process-driven environment.
🧪 Job Details – Safety & PV Coordinator
Company: Syneos Health
Position: Safety & PV Coordinator
Location: Hyderabad / Pune
Experience Required: Minimum 1 Year
Education: B.Pharm / M.Pharm (Mandatory)
Employment Type: Full-Time
Work Mode: Office-Based (Onsite)
Domain: Pharmacovigilance / Drug Safety / PMS
🧾 Key Responsibilities
- Enter and track Individual Case Safety Reports (ICSRs) in PV systems
- Process ICSRs as per SOPs and project-specific safety plans
- Triage cases and assess completeness, accuracy, and reportability
- Code adverse events, medical history, concomitant medications using MedDRA
- Prepare high-quality and compliant case narratives
- Perform duplicate case detection and case reconciliation
- Conduct literature screening and safety review
- Support xEVMPD product record validation and submissions
- Perform manual recoding of product and substance terms
- Participate in SPOR / IDMP related activities
- Ensure documentation is filed in TMF and PV System Master File
- Maintain compliance with ICH-GCP, GVP, and global PV regulations
- Support internal audits and regulatory inspections
🎓 Qualifications & Skills
- B.Pharm / M.Pharm degree (Mandatory)
- Minimum 1 year experience in PMS and spontaneous case processing
- Hands-on knowledge of Argus Safety or LSMV
- Good understanding of clinical trial phases II–IV
- Familiarity with MedDRA coding and drug dictionaries
- Strong documentation and compliance mindset
- Proficiency in MS Word, Excel, PowerPoint, and Outlook
💼 Why Join Syneos Health?
- Work with a company supporting majority of FDA-approved drugs
- Global exposure to post-marketing safety operations
- Strong learning & development programs
- Inclusive, employee-focused work culture
- Clear career progression in Pharmacovigilance & Drug Safety
💰 Estimated Salary (India)
- ₹4,50,000 – ₹7,50,000 per annum
- Salary may vary based on experience, skills, and interview performance
We use a 15-second timer to encourage candidates to read the job description carefully before applying. Please ensure you meet the B.Pharm / M.Pharm and 1+ year PMS experience requirement.
👇 Apply Online 👇
Join our WhatsApp channel
Join Now.jpg)
.jpg)
0 Comments