• Perform medical review of adverse events for investigational and marketed products
• Ensure accurate medical interpretation and assessment of safety cases
• Work closely with Pharmacovigilance (PV/SPVG) teams for case consistency
• Ensure compliance with global regulatory requirements and internal SOPs
• Identify, assess, and manage potential safety signals and risks
• Provide medical input for aggregate safety reports (PSURs, PADERs, Annual Safety Reports)
• Interact with client safety and medical teams as required
• Maintain up-to-date knowledge of drug development and safety information
• Support mentoring and training of internal safety and case processing staff
• Maintain compliance with corporate policies, SOPs, and project-specific guidelines
• MD / MBBS / DO
• Completion of an accredited residency
• 1–2 years of clinical practice experience (preferred)
• Minimum 1 year experience in pharmacovigilance, epidemiology, or pharma/biotech industry preferred
• Strong knowledge of global pharmacovigilance regulations and processes
• Hands-on experience with MedDRA, WHO-DRL, and safety databases (e.g., ARGUS)
• Excellent medical review and safety assessment skills
• Strong written and verbal communication skills (English proficiency required)
• Proficiency in MS Office (Word, Excel, PowerPoint) and safety systems
• Ability to work collaboratively and independently
• Strong presentation, interpersonal, and influencing skills
• Willingness to travel up to 10% if required
• Syneos Health® is a global biopharmaceutical solutions organization operating in 110+ countries , Partnered with 94% of FDA-approved and 95% of EMA-authorized products in recent years
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