Country Patient Safety Head

Major accountabilities:

• Global and /or regional, cross-functional leadership of assigned pharmacovigilance processes across Novartis Divisions to ensure compliance with worldwide regulations with maximum efficiency -Globally responsible for compliance, quality, efficiency and management of Post Marketing and Clinical Trial adverse event handling -Lead management of activities /interfaces with other Global Line Functions management, Investigator Sites, Novartis affiliates and Novartis Sectors management to ensure timeliness, consistency and quality of safety information and to achieve a common understanding of other departmental needs.
• Build high performance safety teams with challenging clear objectives in alignment with Global functional objectives to facilitate implementation of strategic initiatives.
• Accountable for delivery of continuous operations ( quality and compliance) goals.
• Optimize operational efficiency and clinical trial effectiveness by ensuring speedy follow-up for key safety information -Manage direct reports.
• Responsible for ensuring recruitment, development of top safety talent and retention of high performing associates to maintain stable pharmacovigilance operations.
• Ensure regular performance evaluations, development and succession planning -Manage audits and inspections.
• Takes complete responsibility for timely implementation of necessary corrective and preventive actions (CAPA commitments).
• Maintain inspection readiness at all times to minimize findings -Distribution of marketing samples (where applicable)

Key performance indicators:

• Adherence to Novartis policy and guidelines -Project and stakeholder feedback -Operational risk mitigation and audit/inspection findings -Quality and timely reporting of KPI and safety reports/updates -Results of audits/inspections

Minimum Requirements:
Work Experience:

• Critical Negotiations.
• People Challenges.
• Operations Management and Execution.
• Collaborating across boundaries.
• People Leadership.

Skills:

• Clinical Trial.
• Databases.
• Employee Training.
• Pharmacovigilance.
• Project Management.
• Reporting.
• Safety Science.
• Team Management.

Languages :

• English.