Safety Physician

About the role & responsibilities
• Perform medical review of adverse events for investigational and marketed products
• Ensure accurate medical assessment using MedDRA, WHO-DRL and ARGUS safety database
• Maintain compliance with global pharmacovigilance regulations and internal SOPs
• Identify, communicate and manage potential safety risks and safety signals
• Provide medical review for aggregate safety reports including PSURs, PADERs and annual reports
• Collaborate with safety and pharmacovigilance teams for consistent case assessment
• Interact with sponsor safety and medical teams when required
• Support training and mentoring of pharmacovigilance associates
• Maintain continued medical education and PV expertise

Qualification
• MD / MBBS / DO
• Completed accredited residency

Experience
• 1–2 years of clinical practice
• Minimum 1 year experience in Pharmacovigilance / Drug Safety in pharma, CRO or biotech

Skills
• Knowledge of global PV regulations
• MedDRA and WHO-DRL coding understanding
• ARGUS safety database exposure
• Safety signal identification and risk assessment
• Strong documentation and communication skills

About the company
• Syneos Health is a global biopharmaceutical solutions organization operating in 110+ countries, supporting clinical development, medical affairs and commercialization worldwide

Location & travel
• Location as per project | Travel up to 10%