LATAM Senior Safety Operations Manager
- Hiring from
- Argentina, Brazil, Mexico
- Work type
- Hybrid
- Posted
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At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Job Function:
Product SafetyJob Sub Function:
PharmacovigilanceJob Category:
People LeaderAll Job Posting Locations:
Buenos Aires, Argentina, Mexico City, Mexico, São Paulo, BrazilJob Description:
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
Learn more at https://www.jnj.com/.
We are searching for the best talent for this LATAM Senior Safety Operations Manager.
Purpose: The LATAM Senior Safety Operations Manager provides strategic and operational leadership for Safety Operations across the region, translating Global and Regional Medical Safety priorities into an effective LATAM operating model and ensuring compliant, timely, and high-quality pharmacovigilance execution. The role is accountable for proactively managing operational, regulatory, vendor, and business continuity risks while serving as a senior regional decision-maker and strategic partner who aligns Local, Regional, and Global stakeholders to drive high-impact, risk-based decisions that strengthen compliance, operational excellence, business continuity, and patient safety across LATAM.
Key Accountabilities
1. Regional Safety Operations Strategy and Governance
- Own and execute the regional Safety Operations strategy, operating model, priorities, and governance framework in alignment with LATAM Medical Safety objectives, local regulations, and J&J global policies and procedures.
- Translate evolving regulatory requirements and business needs into regional priorities, resource plans, standards, and implementation decisions.
- Represent LATAM Safety Operations in relevant local, regional, and global governance forums, providing clear recommendations, risk assessments, and escalation when required.
2. End-to-End Pharmacovigilance Operations and Compliance
- Provide regional accountability for the compliant and timely execution of Individual Case Safety Report activities, including adverse events, adverse events associated with 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, procedural requirements, and SUMMIT training activities remain current, effective, and aligned with applicable requirements.
- Partner with Local Safety Officers to ensure Local Operating Company pharmacovigilance activities and applicable partner agreements are managed consistently and compliantly.
3. Vendor and Partner Performance Management
- Lead the governance and strategic oversight of external vendors and internal partners supporting adverse event case processing and other Safety Operations activities.
- Establish performance expectations, monitor service quality, compliance, capacity, timelines, and contractual deliverables, and make decisions regarding prioritization, remediation, escalation, and performance improvement.
- Drive effective issue resolution and continuity plans to reduce operational risk and protect regulatory and business commitments.
4. Risk Management, Inspection Readiness, and CAPA Oversight
- Own the regional Safety Operations risk-management approach, identifying, assessing, prioritizing, mitigating, and escalating compliance and operational risks based on potential patient, regulatory, and business impact.
- Lead and co-lead readiness activities for internal audits, partner audits, and Health Authority inspections, ensuring sustained inspection readiness across the region.
- Oversee the development, approval, execution, and effectiveness monitoring of responses, remediation plans, and applicable Corrective and Preventive Actions, with timely engagement of relevant stakeholders.
5. Performance, Systems, and Continuous Improvement
- Define and monitor regional metrics, Key Performance Indicators, quality indicators, and dashboards to evaluate compliance, quality, productivity, timeliness, capacity, and risk.
- Use performance insights and trend analysis to make evidence-based decisions, address systemic issues, and drive process simplification, standardization, automation, and sustainable improvement.
- Provide strategic direction for systems and dashboards owned or used by the LATAM Medical Safety team, ensuring appropriate governance, adoption, and business value.
6. People Leadership and Organizational Capability
- Lead, coach, and develop the Safety Operations team, setting clear priorities, decision rights, performance expectations, and accountability for outcomes.
- Build critical technical, operational, leadership, and risk-management capabilities; identify development and succession needs; and prepare talent for expanded responsibilities.
- Promote an inclusive, collaborative, and Credo-based culture that supports engagement, psychological safety, high performance, and timely completion of required training.
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Required Skills:
Preferred Skills:
Developing Others, Global Market, Inclusive Leadership, Leadership, Medicines and Device Development and Regulation, Operations Management, Performance Measurement, Pharmacovigilance, Quality Control (QC), Quality Management Systems (QMS), Regulatory Affairs Management, Report Writing, Safety Investigations, Safety-Oriented, Safety Reporting, Serious Adverse Event Reporting, Team ManagementAbout Us
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.