Description Senior Safety & PV Ops Specialist - Technology Support (ARGUS Console or Veeva Safety preferred) - Argentina, Mexico, Brasil - Remote
Job ResponsibilitiesPosition Summary:The Senior Safety & PV Technology Support role provides advanced functional and technical support for pharmacovigilance systems and safety technology platforms. This individual serves as a senior point of contact for issue triage, resolution coordination, user support, operational continuity, and continuous improvement across the safety technology ecosystem. The role partners closely with Safety Operations, IT, vendors, validation, quality, and business stakeholders to ensure systems remain compliant, reliable, and aligned with operational and regulatory requirements.
Key Responsibilities:- Provide senior-level support for PV 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, ensuring timely resolution and appropriate stakeholder communication.
- Partner with IT, vendors, and internal business teams to investigate system issues, identify root cause, validate fixes, and confirm business readiness for deployment.
- Support incident, problem, change, release, and enhancement management activities in accordance with approved processes and applicable regulatory expectations.
- 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 to recommend process improvements, automation opportunities, and long-term stabilization actions.
- Support validation, testing, and documentation activities for system changes, upgrades, integrations, and configuration updates.
- Develop and maintain support documentation, job aids, knowledge articles, process guides, and escalation pathways for end users and support teams.
- Provide guidance and coaching to junior support team members, helping ensure consistent issue handling, documentation quality, and adherence to established procedures.
- Collaborate with Safety Operations and Technology Oversight stakeholders to ensure system support activities align with compliance, quality, and business continuity expectations.
Required Qualifications:- 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.
- Demonstrated ability to troubleshoot system issues, assess business impact, document findings, and coordinate resolution across cross-functional teams.
- Experience working within 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.
Desirable Qualifications:- Argus Safety
- Veeva Safety
- 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.
Core Competencies:- 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 with the ability to influence across business, technology, quality, and vendor teams.
- Continuous improvement mindset with the ability to identify recurring issues and drive sustainable solutions.
Get to know Syneos HealthOver the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.
http://www.syneoshealth.com
Additional InformationTasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms.
