Risk Management Manager

hace 3 semanas

Ribamontán al Mar, España Novartis Farmacéutica A tiempo completo
Job Description

The Risk Management Manager oversees activities to identify and categorize risks impacting the Vigilance system and the broader Pharmacovigilance (PV) organization.

This role leads strategic risk management projects within the Novartis Vigilance System, developing insights and mitigation plans to identify and act on improvement opportunities early.

  • Trending and management of Quality Issues and Quality Events, including receipt, entry into AQWA / 1QEM, timely investigations, implementation of CAPAs with evidence, effectiveness checks, and closure.
  • Drive development of insights and mitigation plans to identify and act on improvement opportunities early.
  • Lead strategic risk management projects within the Novartis Vigilance System.
  • Develop and maintain guidance documents and training materials for Patient Safety staff on handling Quality Issues and Events.
  • Monitor compliance with processes and standards, addressing deficiencies through strategic initiatives.
  • Collaborate across functions to produce metrics and trend analyses to identify risks impacting the Vigilance System and CMO & PS organizations.
  • Work with global teams and third parties to establish joint accountabilities.
  • Maintain procedural documents, including ownership of relevant PSMF sections and annexes.
  • Review emerging regulations, assess impacts, and implement necessary process changes for compliance.
  • Serve as a subject matter expert during audits and inspections, leading response preparations and CAPA implementations.
  • Prepare reports and presentations on risk assessments, escalating key issues to senior management.
  • Support operational metrics and risk committee management, including scheduling, agenda setting, and follow-up.
About Us

Novartis is committed to fostering an inclusive, diverse work environment reflecting the communities we serve.

Your Qualifications
  • At least 4 years of experience in the pharmaceutical industry, especially pharmacovigilance.
  • Experience in project management and leading work groups.
  • Strong interpersonal skills to interact with diverse stakeholders.
  • Excellent negotiation, presentation, and communication skills, with the ability to operate effectively internationally and cross-functionally.
  • Strong analytical skills.
  • Ability to mentor and coach team members.
Educational Background

PharmD, MSc in Life Sciences, or equivalent.

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