Role & Responsibilities
• Process and triage Individual Case Safety Reports (ICSRs)
• Ensure data accuracy, completeness, and regulatory compliance in safety reporting
• Perform medical coding of adverse events, medical history, and medications using MedDRA
• Support xEVMPD submissions and SPOR/IDMP activities
• Maintain documentation within TMF and Pharmacovigilance system master files
• Collaborate with global safety teams to meet regulatory timelines
Qualification
• Degree in Pharmacy, Life Sciences, or related healthcare discipline (e.g., B.Pharm, M.Pharm, Pharm.D, MSc, BDS)
Experience
• 2.6 to 4.5 years of hands-on experience in ICSR case processing
• Proven experience with Argus, ArisG, or LSMV safety databases
• Strong understanding of global pharmacovigilance regulations
• Knowledge of MedDRA coding and safety reporting workflows
Skills
• Expertise in pharmacovigilance and safety reporting
• Ability to manage and maintain accurate documentation
• Strong collaboration and communication skills in a global setting
About The Company
• Syneos Health – A global biopharmaceutical solutions organization, Syneos Health provides a full spectrum of clinical, medical affairs, and commercialization services. The company is committed to delivering innovative solutions across the drug development lifecycle, from preclinical to post-marketing. Syneos Health fosters a collaborative work culture with global exposure and career growth opportunities.
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