Director - Aggregate Reporting, Risk Management & Surveillance (ARRMS)

Responsibilities

• Establish and optimize processes, tools, and frameworks to enhance efficiency, quality, and compliance in aggregate reporting, surveillance and risk management
• Drive innovation to streamline operations and improve regulatory Team & Performance Management:
• Lead, mentor, and manage a team of safety scientists, report writers, safety physicians, and quality reviewers.
• Oversee resource planning, workload management, and performance tracking to ensure efficiency and talent
• Champion a culture of quality and compliance, ensuring robust peer reviews and adherence to Regulatory Compliance & Quality Oversight:
• Oversee the end-to-end production and quality review of Global and local aggregate reports (for example, PBRER/PSUR, DSUR, RMP, PADER, CAR, MDR PSUR, Cosmetovigilance reports ).
• Ensure compliance with major PV regulations such as but not limited to ICH, GVP, FDA, EU MDR, and Health Canada regulatory
• Identify and mitigate risks impacting timelines, quality, or regulatory Client & Stakeholder Engagement:
• Drive client satisfaction by addressing concerns, implementing feedback-driven improvements, and maintaining compliance.
• Support business development through proposal responses, client presentations, and service expansion strategies.
• Ensure adherence to sponsor SOPs, templates, and guidelines across
• Oversee SLA/KPI compliance, drive process improvements, and manage escalations
• Lead and support internal and external audits, ensuring timely resolution of
• Manage aggregate reporting and surveillance projects to ensure compliance with safety regulations and guidelines.
• Manage the day-to-day operations within project and liaise with the team and management to ensure effective functioning of the team and address any concerns or issues.
• Ensure a ‘true global’ model in place through collaboration with regions around the globe to adapt best practices and consistent approach throughout customer’s business.
• Ensure compliance with appropriate contract Change Management practices.
• Ensure Business Continuity has been planned and is operationalized when the need arises Secondary Responsibilities:
• Enhance workflows and efficiencies by developing new services, streamlining processes, and improving reporting accuracy.
• Establish best practices through SOPs, templates, and work instructions for