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Role & Responsibilities
• Serve as primary interface between sponsors, vendors and internal Safety & PV teams
• Provide line management to Safety and Pharmacovigilance associates and managers
• Oversee operational delivery as per Safety Management Plans and contracted scope
• Monitor quality, productivity and KPIs and resolve performance gaps
• Lead PV projects and ensure timely safety reporting submissions
• Review and approve study budgets, invoicing and financial forecasts
• Act as escalation point for sponsors and provide regular project updates
• Coordinate with Clinical, Data Management, Regulatory and other functions
• Develop, review and approve SOPs, work instructions and process improvements
• Support business development activities, proposals and bid defenses
• Review safety sections of protocols, CRFs and SAE forms
• Ensure compliance with ICH-GCP, GVP modules, global regulations and internal SOPs
• Participate in audits, inspections, CAPA management and inspection readiness
• Provide PV training and expert consultation to internal teams and clients
Qualification
• Bachelor’s degree in Life Sciences, Pharmacy, Nursing or related healthcare discipline
Experience
• Extensive leadership experience in Safety & Pharmacovigilance within CRO or global PV environments
Skills
• Strong knowledge of GVP, ICH guidelines and global safety regulations
• Proven people management and project leadership abilities
• Financial acumen for budget management and invoicing
• Proficiency in MS Word, Excel, PowerPoint, Visio and Outlook
• Excellent communication, stakeholder management and presentation skills
• Ability to manage multiple priorities in a fast-paced, matrix environment
About the Company
Syneos Health® is a global biopharmaceutical solutions organization delivering integrated clinical development, medical affairs and commercial services, partnering with leading pharmaceutical companies worldwide to accelerate drug development and improve patient outcomes through innovation, quality and compliance.