Senior Patient Safety Manager

Sandoz UK & Ireland


Date: 5 hours ago
City: Camberley, England
Contract type: Full time
Job Description

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.
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