Location: Hyderabad, India
Company: Syneos Health
Job ID: 25106472
Employment Type: Full-Time
Experience Required: 2.6+ years (Not suitable for freshers)
Preference: Immediate joiners
About the Company
Syneos Health is a leading global biopharmaceutical solutions organization that accelerates clinical development and commercialization. With a strong presence across global markets, the company partners with innovators to deliver high-impact healthcare outcomes through integrated clinical, medical, and commercial services.
Job Overview
The Safety & Pharmacovigilance Specialist I plays a critical role in Individual Case Safety Report (ICSR) processing, medical coding, and regulatory compliance. This position is ideal for professionals with hands-on experience in pharmacovigilance operations, particularly in case processing, narrative writing, and safety database management.
Key Responsibilities
Perform end-to-end ICSR processing in compliance with global pharmacovigilance regulations
Enter and manage case data within safety databases and PV tracking systems
Conduct triage of ICSRs, ensuring completeness, accuracy, and regulatory reportability
Perform MedDRA coding for adverse events, medical history, and indications
Execute WHO Drug coding and maintain drug dictionaries
Develop detailed and medically accurate case narratives
Identify data gaps, raise queries, and ensure timely follow-up and resolution
Support expedited reporting in accordance with global regulatory timelines
Perform duplicate detection and reconciliation of safety cases
Contribute to xEVMPD submissions and SPOR/IDMP-related activities
Conduct literature screening and safety signal identification
Perform quality review (QC) of safety cases
Ensure proper documentation within Trial Master File (TMF) and Pharmacovigilance System Master File (PSMF)
Participate in audits, inspections, and compliance activities
Maintain adherence to ICH-GCP, GVP guidelines, SOPs, and global regulatory frameworks
Required Qualifications
Bachelor’s or Master’s degree in Life Sciences or Healthcare:
B.Pharm, M.Pharm, BDS, BMS, or MBBS (BSc / MSc not eligible as per role requirement)
Minimum 2.6 years of experience in Pharmacovigilance / Drug Safety / ICSR Processing
Strong understanding of global safety reporting requirements and regulatory compliance
Hands-on experience with safety databases (Argus, ArisG, or similar)
Proficiency in MedDRA and WHO Drug coding
Excellent attention to detail, analytical thinking, and case assessment skills
Strong communication and documentation capabilities
Role Classification Clarity
Safety & PV Specialist I: Minimum 2.6 years experience
Safety & PV Specialist II: Minimum 4+ years experience
Freshers are not eligible for this role. Entry-level candidates should target Drug Safety Associate or PV Case Processing trainee roles.
Why This Role Matters
Direct involvement in global drug safety and patient risk monitoring
Exposure to regulatory reporting across FDA, EMA, and global markets
Opportunity to work on high-volume, real-world safety data
Strong career growth pathway within Pharmacovigilance and Drug Safety domains
About Syneos Health’s Global Impact
Over the past five years, Syneos Health has contributed to:
94% of novel FDA-approved drugs
95% of EMA-authorized products
200+ global clinical studies
675,000+ clinical trial patients across 73,000 sites
Important Disclaimer
This job description outlines key responsibilities but is not exhaustive. Additional tasks may be assigned based on business needs. Equivalent qualifications and transferable skills may be considered as per company discretion.
How to Apply
Apply directly through the company’s official careers page or explore verified global Pharmacovigilance jobs on ThePharmaDaily.com
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Netherlands |Remote Australia :
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Queensland |Melbourne :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
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Tallinn |Hà Nội :
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