Job Opportunities in Taiwan


July 16, 2024

Novartis

台北市

OTHER


Country Patient Safety Head

Summary
  • Monitors and audits the company’s drug, biologics or medical devices surveillance program including the intake, evaluation, processing and follow-up on adverse reports. Participates in the resolution of any legal liability and in complying with government regulations. Ensures accurate receipt, maintenance and assessment against product labeling. Reports events or reactions as required by regulatory agencies including adverse events data from clinical trials, spontaneous or solicited sources, periodic and experience reports. May provide trending and safety signal detection and assessment. Supports all clinical trial activity and post marketing.
About the Role
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:

  • 2+ years experience in People Leadership.
  • Critical Negotiations.
  • People Challenges.
  • Operations Management and Execution.
  • Collaborating across boundaries.
Skills:
  • Clinical Trial.
  • Databases.
  • Employee Training.
  • Pharmacovigilance.
  • Project Management.
  • Reporting.
  • Safety Science.
  • Team Management.
Languages :
  • English.
  • Mandarin
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

Division
Development
Business Unit
Innovative Medicines
Location
Taiwan
Site
Taipei
Company / Legal Entity
TW03 (FCRS = TW003) Novartis (Taiwan) Co. Ltd
Functional Area
Research & Development
Job Type
Full time
Employment Type
Regular
Shift Work
No

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

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