Product Safety, PV & Risk Management
Accountable for all core pharmacovigilance activities, including case processing, causality and labeledness assessment, signal detection, safety evaluation, risk mitigation, and crisis management. Ensures implementation of risk management measures and regulatory deliverables (e.g. PSURs, safety variations) in line with global GVP requirements.
Strategic Safety & Regulatory Leadership
Defines and drives the global product safety strategy and ensures integration of safety insights into the product lifecycle. Responsible for regulatory PV compliance, inspection readiness, and alignment with global health authority expectations.
Team Leadership & Operational Governance
Provides disciplinary and functional leadership to the PV team, including resource allocation, budgeting, task prioritization, capability development, and final decision-making responsibility.
Cross-Functional & External Stakeholder Management
Ensures strong alignment with internal stakeholders (e.g. SCM, Therapeutic Areas, Quality, Regulatory) and acts as central escalation point (SPOC). Manages relationships with external partners, vendors, and service providers to ensure quality and compliance.
Continuous Improvement & Regulatory Intelligence
Monitors global regulatory developments, evaluates new PV tools and processes, and drives continuous improvement of safety systems and methodologies in collaboration with medical and scientific functions.
