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Looking to grow your career in pharmacovigilance (PV) and drug safety? A leading global CRO, Syneos Health, is hiring Safety & PV Specialist I professionals for office-based roles in Hyderabad, Gurugram, and Pune. This opportunity is ideal for candidates with hands-on experience in ICSR processing, MedDRA coding, and safety database management.
With strong exposure to global regulatory frameworks like ICH-GCP, GVP, and FDA/EMA guidelines, this role offers a solid pathway into advanced pharmacovigilance operations.
๐ Job Overview
- Role: Safety & PV Specialist I
- Company: Syneos Health
- Locations: Hyderabad, Gurugram, Pune (Office-based)
- Experience: Minimum 2.6 years in Pharmacovigilance
- Employment Type: Full-time
- Department: Clinical Solutions / Drug Safety
๐ผ Key Responsibilities
As a Safety & PV Specialist, you will handle end-to-end pharmacovigilance operations, including:
- Processing and tracking ICSRs (Individual Case Safety Reports)
- Performing case triage and data validation for completeness and accuracy
- Coding adverse events and medications using MedDRA
- Writing narrative summaries for safety cases
- Managing duplicate case detection and reconciliation
- Performing literature screening for safety signals
- Supporting xEVMPD submissions and SPOR/IDMP activities
- Ensuring compliance with SOPs, GVP, ICH, and regulatory guidelines
- Contributing to TMF (Trial Master File) and safety documentation
- Participating in audits and quality reviews of ICSRs
๐ Eligibility & Qualifications
- Required Degrees: B.Pharm, M.Pharm, PharmD, BDS, BMS, MBBS
- โ Note: BSc / MSc candidates are not eligible
- Experience:
- Safety & PV Specialist I: 2.6+ years
- Safety & PV Specialist II: 4+ years
๐ง Required Skills
- Strong knowledge of pharmacovigilance workflows
- Experience with safety databases (Argus, ArisG, etc.)
- Proficiency in MedDRA coding and ICSR lifecycle
- Understanding of global drug safety regulations
- Attention to detail and compliance mindset
๐ Benefits of Working at Syneos Health
- Career growth in clinical research and pharmacovigilance
- Exposure to global drug safety projects
- Structured training & development programs
- Inclusive and collaborative work culture
- Opportunity to work on FDA-approved and EMA-authorized products
๐ฐ Salary Insights (India)
- Estimated Salary Range: โน3.5 LPA โ โน8 LPA
(Based on experience, role level, and industry benchmarks for PV specialists in India)
๐ How to Apply
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