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Syneos Health — a global biopharmaceutical solutions leader — is hiring a Safety & Pharmacovigilance Specialist I in Gurugram, India. This role is ideal for experienced professionals (2.5–4 years) from pharmacy or medical backgrounds looking to advance their careers in pharmacovigilance (PV) and drug safety operations.
As part of the Syneos Health team, you’ll help ensure drug safety through ICSR processing, case triage, data coding, and regulatory compliance, contributing to safer therapies worldwide.
🧠 Key Responsibilities
As a Safety & PV Specialist I, you will:
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- Perform ICSR case processing, including data entry, triage, and evaluation of case completeness.
- Enter and manage data in Argus or Aris-G safety databases.
- Code medical events, concomitant medications, and medical history using MedDRA.
- Prepare narrative summaries and resolve case queries with accuracy and timeliness.
- Support expedited and periodic safety reporting in compliance with global regulations (GVP, ICH, and GCP).
- Conduct literature screening and maintain drug dictionaries.
- Manage xEVMPD submissions, SPOR/IDMP activities, and duplicate case identification.
- Ensure quality control of ICSRs and maintain documentation in the Trial Master File (TMF).
- Stay up-to-date with global pharmacovigilance regulations and SOPs.
🎓 Qualifications
To qualify for this role, candidates must have:
- Education: B.Pharm, M.Pharm, BDS, BMS, or MBBS (No BSc/MSc)
- Experience: 2.5 to 4 years in pharmacovigilance, drug safety, or ICSR case processing
- Tools Knowledge: Argus, Aris-G, MedDRA
- Skills: Attention to detail, regulatory compliance understanding, strong data handling skills, and teamwork abilities
💼 Why Join Syneos Health
- Opportunity to work with one of the world’s top biopharmaceutical research organizations.
- Exposure to global drug safety operations and compliance.
- Career growth supported by training and mentorship.
- Inclusion-focused culture through Syneos’ Total Self philosophy — fostering authenticity and belonging.
- Competitive compensation and benefits aligned with experience.
📍 Job Details
- Position: Safety & PV Specialist I
- Company: Syneos Health
- Location: Gurugram, India (Office-based / Hybrid)
- Experience Required: 2.5–4 years
- Education: B.Pharm / M.Pharm / BDS / BMS / MBBS
- Salary Range: ₹6,00,000 – ₹9,00,000 per annum (based on experience)
- Application Deadline: November 14, 2025
📝 How to Apply
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