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Role & Responsibilities
• Perform medical review of adverse events for investigational and marketed products
• Assess and interpret ICSRs using MedDRA and safety databases such as ARGUS
• Ensure compliance with global pharmacovigilance regulations and SOPs
• Provide medical input for PSURs, PADERs and other aggregate safety reports
• Identify, evaluate and manage potential safety signals
• Liaise with client safety and medical teams for case assessments
• Maintain medical surveillance of clinical and post-marketing safety data
• Support mentoring and training of pharmacovigilance staff
• Maintain ongoing medical education in drug safety and clinical development
Qualification
• MD / MBBS / DO from a recognized institution
• Completed accredited residency
Experience
• 1–2 years of clinical practice experience preferred
• Minimum 1 year experience in pharmacovigilance / pharmaceutical or biotechnology industry preferred
Skills
• Strong knowledge of global pharmacovigilance regulations
• Proficiency with MedDRA, ARGUS and safety databases
• Excellent written and verbal communication skills
• Strong analytical and risk assessment abilities
• Proficiency in MS Word, Excel, PowerPoint and safety systems
• Ability to collaborate across cross-functional teams
About the Company
Syneos Health® is a global, fully integrated biopharmaceutical solutions organization operating across more than 110 countries. With over 29,000 employees, Syneos Health supports clinical development, medical affairs and commercialization for pharmaceutical and biotech companies, having contributed to the majority of recent FDA and EMA-approved therapies worldwide.