About the role & responsibilities
• Perform medical review of adverse event cases for investigational and marketed products
• Ensure accurate medical assessment using MedDRA, WHO-DRL and safety databases (ARGUS)
• Maintain regulatory and SOP compliance for safety reporting and surveillance
• Identify, communicate and manage safety signals and potential safety risks
• Review aggregate safety reports including PSURs, PADERs and annual safety reports
• Provide scientific and medical input to pharmacovigilance teams
• Interact with sponsor safety and medical teams
• Support training, mentoring and development of PV associates
• Maintain continuous medical education and PV expertise
Qualification
• MD / MBBS / DO with completed residency
Experience
• 1–2 years clinical practice experience
• 1+ year experience in Pharmacovigilance / Drug Safety in pharma, CRO or biotech
Skills
• Strong knowledge of global PV regulations
• MedDRA & WHO-DRL coding understanding
• ARGUS safety database experience
• Signal detection & case medical review
• Scientific writing & communication
• Regulatory compliance & documentation
About the company
• Syneos Health is a global biopharmaceutical solutions organization operating across 110+ countries, supporting drug development, medical affairs and commercialization programs worldwide
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