Safety & Pharmacovigilance (PV) Specialists
About the Role
Role & Responsibilities
• Process and triage Individual Case Safety Reports (ICSRs) in compliance with global regulations
• Ensure data accuracy, completeness, and regulatory timelines for safety reporting
• Code medical events, medical history, and concomitant medications using MedDRA
• Work on xEVMPD submissions and support SPOR/IDMP activities
• Maintain compliant documentation within PV systems and Trial Master Files (TMF)
• Support global pharmacovigilance and drug safety operations
• Collaborate with cross-functional and international teams to deliver high-quality PV outputs
• Adhere to GxP guidelines and pharmacovigilance standard operating procedures
Qualification
• B.Pharm / M.Pharm / Pharm.D
• MSc (Life Sciences) or equivalent
Experience
• 2.6 to 4.5 years of hands-on experience in ICSR case processing
Skills
• Strong experience with safety databases such as Argus, ArisG, or LSMV
• Sound knowledge of pharmacovigilance regulations and GxP guidelines
• Attention to detail with strong quality and compliance focus
• Effective communication and documentation skills
About the Company
• Syneos Health is a leading global biopharmaceutical solutions organization, Provides integrated clinical, medical affairs, and commercial services
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