Senior Safety Operations Manager

Johnson & Johnson

. Own and execute the regional Safety Operations strategy, operating model, priorities, and governance framework across LATAM.

Posted 10/14/2026full-timeSão Paulo • BrazilSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in pharmacovigilance operations, including adverse event case processing and compliance with local regulations. Proven leadership in managing safety operations, vendor governance, and performance improvement initiatives.

Highest-signal resume keywords

Pharmacovigilance OperationsRisk ManagementVendor GovernanceMetrics Definition and MonitoringProcess Improvement

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Adverse Event Case ProcessingProduct Quality ComplaintsHealth Authority SubmissionsCorrective and Preventive Actions (CAPA)Quality Management Systems (QMS)Safety ReportingSerious Adverse Event ReportingPerformance MeasurementTrend AnalysisReport Writing

Soft Skills

LeadershipTeam ManagementCollaborationCoachingDecision Making

Tools & Technologies

Pharmacovigilance PlatformsSUMMIT Training ActivitiesDashboards

Industry Keywords

Regulatory Affairs ManagementComplianceOperational RisksService QualityContinuous Improvement

About the role

Key responsibilities & impact

Own and execute the regional Safety Operations strategy, operating model, priorities, and governance framework across LATAM.
Translate evolving regulatory requirements and business needs into regional priorities, resource plans, standards, and implementation decisions.
Represent LATAM Safety Operations in local, regional, and global governance forums with recommendations, risk assessments, and escalations.
Provide regional accountability for compliant and timely Individual Case Safety Report activities, including adverse events, Product Quality Complaints, special situations, periodic literature searches, and submissions to the Global Processing Center and Local Health Authorities.
Ensure pharmacovigilance platforms, systems, controlled documents, procedures, and SUMMIT training activities remain current and compliant.
Partner with Local Safety Officers to manage Local Operating Company pharmacovigilance activities and partner agreements.
Lead governance and strategic oversight of external vendors and internal partners supporting safety operations.
Monitor vendor and partner service quality, compliance, capacity, timelines, and contractual deliverables; drive remediation and performance improvement.
Own the regional Safety Operations risk-management approach and mitigate or escalate compliance and operational risks.
Lead readiness activities for internal audits, partner audits, and Health Authority inspections.
Oversee responses, remediation plans, and applicable Corrective and Preventive Actions (CAPA).
Define and monitor regional metrics, KPIs, quality indicators, and dashboards.
Drive process simplification, standardization, automation, and sustainable improvement using performance insights and trend analysis.
Provide strategic direction for systems and dashboards used by the LATAM Medical Safety team.
Lead, coach, and develop the Safety Operations team while establishing priorities, decision rights, performance expectations, and accountability.
Build organizational capabilities, identify development and succession needs, and promote an inclusive, collaborative, Credo-based culture.

Requirements

What you’ll need

Experience and qualifications are not explicitly stated in the posting.
Knowledge of pharmacovigilance operations, adverse event case processing, product quality complaints, special situations, periodic literature searches, and health-authority submissions.
Knowledge of applicable local regulations, J&J global policies and procedures, controlled documents, procedural requirements, and SUMMIT training activities.
Experience with vendor and partner governance, service quality, compliance, capacity, timelines, contractual deliverables, remediation, escalation, and performance improvement.
Experience with risk management, internal and partner audits, Health Authority inspections, remediation plans, and Corrective and Preventive Actions (CAPA).
Experience defining and monitoring metrics, Key Performance Indicators, quality indicators, and dashboards.
Experience with process simplification, standardization, automation, trend analysis, and continuous improvement.
Leadership experience developing technical, operational, leadership, and risk-management capabilities.
Preferred skills include Pharmacovigilance, Operations Management, Quality Management Systems (QMS), Regulatory Affairs Management, Safety Reporting, Serious Adverse Event Reporting, Leadership, Team Management, Performance Measurement, Report Writing, and Safety Investigations.