Risk Management Director

hace 4 días

Madrid, Madrid, España Novartis A tiempo completo
About the Role

The Risk Management Director leads activities and initiatives designed to identify and categorize risks that potentially impact the Vigilance system and the broader PS&PV organization as well as the preparation of action plans for PS&PV leadership endorsement.

Key Responsibilities:
  • Receipt of Quality Issues and Quality Events
  • Entry into AQWA/1QEM
  • Timely completion of investigations
  • Implementation of appropriate CAPAs and availability of appropriate evidence
  • Completion of effectiveness checks
  • Timely closure in AQWA/1QEM

The Risk Management Director drives the development of actionable insights and mitigation plans to ensure that any opportunities for improvement are identified and acted upon as early as possible.

Leadership and Collaboration:
  • Lead and support strategic projects related to Risk Management of the Novartis Vigilance System
  • Collaborate with the Compliance, Process Excellence, QPPV Office and other functions to produce metrics and complete trend analyses designed to identify areas of risk with impact on the Vigilance System and/or CMO&PS organization
  • Collaborate with other Global Line Functions across Novartis Divisions and Third Parties to establish and meet joint accountabilities
Expertise and Support:
  • Act as a subject matter expert during audits and inspections, lead the preparation of responses to findings and the development and implementation of corrective and preventative actions
  • Support the review of emerging worldwide regulations, performing impact assessments, and driving process changes required to ensure ongoing compliance to global regulatory requirements
Requirements:
  • Minimum 4 years of experience in the pharmaceutical industry, particularly pharmacovigilance
  • Experience in project management and demonstrated ability to lead work groups
  • Ability to deal and interact with a wide variety of people at all levels
  • Strong negotiation, presentation and communication skills, and ability to operate effectively in an international environment and across functions
  • Excellent analytical skills
  • Ability to mentor and coach
Education:
  • PharmD, MSc Degree in Life Sciences or equivalent
Language:
  • English

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