Syneos Health
10,000+ employees
🏥 Healthcare
💼 Consulting
📦 Logistics
Healthcare • Consulting • Logistics
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.
Senior Safety & PV Ops Specialist – Technology Support, ARGUS Console, Veeva Safety
🔥 11 minutes ago
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Syneos Health
10,000+ employees
🏥 Healthcare
💼 Consulting
📦 Logistics
Healthcare • Consulting • Logistics
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.
📋 Description
• Provide senior-level support for pharmacovigilance technology platforms, including safety databases, workflow tools, reporting solutions, integrations, and related business applications • Lead initial triage, impact assessment, prioritization, and coordination of production support issues • Communicate with stakeholders to ensure timely issue resolution • Partner with IT, vendors, and internal business teams to investigate system issues, identify root causes, validate fixes, and confirm deployment readiness • Support incident, problem, change, release, and enhancement management activities • Serve as a subject matter expert for PV system functionality, business workflows, user access, data flow, and operational support procedures • Monitor support trends, recurring issues, and user pain points • Recommend process improvements, automation opportunities, and long-term stabilization actions • Support validation, testing, and documentation for system changes, upgrades, integrations, and configuration updates • Develop and maintain support documentation, job aids, knowledge articles, process guides, and escalation pathways • Provide guidance and coaching to junior support team members • Collaborate with Safety Operations and Technology Oversight stakeholders to align support with compliance, quality, and business continuity expectations
🎯 Requirements
• Minimum 5+ years of experience in pharmacovigilance, drug safety, safety systems, technology support, or a related regulated environment • Strong understanding of PV business processes, including case intake, case processing, submissions, reporting, data quality, and safety database workflows • Experience supporting safety systems such as Oracle Argus Safety or comparable PV platforms • Ability to troubleshoot system issues, assess business impact, document findings, and coordinate resolution across cross-functional teams • Experience with regulated system support processes, including change control, testing, validation documentation, incident management, and audit-ready documentation practices • Strong communication, stakeholder management, analytical, and organizational skills • Ability to manage multiple priorities, support escalations, and operate effectively in a fast-paced, matrixed environment • Argus Safety or Veeva Safety experience preferred • Experience supporting Argus upgrades, migrations, integrations, automation initiatives, or AI-enabled PV technology solutions • Familiarity with reporting tools, data transfer processes, E2B/ICH standards, MedDRA coding, or safety data exchange concepts • Experience with ticketing systems, knowledge management tools, and service-level reporting • Knowledge of GxP, computerized system validation, quality management, CAPA, and inspection readiness expectations • Experience mentoring team members or acting as a senior escalation point for operational support activities • Customer-focused support mindset with strong ownership and follow-through • Ability to translate technical issues into clear business impact and actionable next steps • Strong attention to detail, documentation discipline, and commitment to compliance • Collaborative approach across business, technology, quality, and vendor teams • Continuous improvement mindset and ability to drive sustainable solutions
🏖️ Benefits
• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition • Total rewards program • Inclusive culture • Comprehensive resources including emerging technologies, data, science and knowledge sharing • Opportunities for career paths and employment progression
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