Risk Management Manager

hace 3 semanas


Madrid, Madrid, España Advanced Accelerator Applications (Italy) - S... A tiempo completo
About the Role

The Risk Management Manager leads activities and initiatives designed to identify and categorize risks that potentially impact the Vigilance system and the broader organization. This includes the preparation of action plans for leadership endorsement and ensuring oversight of management of Patient Safety Quality Issues and Quality Events in AQWA/1QEM.

Key Responsibilities:

  • Quality Issue and Quality Event Management:
    • Receipt and entry of Quality Issues and Quality Events into AQWA/1QEM
    • Timely completion of investigations and implementation of appropriate CAPAs
    • Completion of effectiveness checks and timely closure in AQWA/1QEM
  • Strategic Projects and Insights:
    • Drive the development of actionable insights and mitigation plans to ensure opportunities for improvement are identified and acted upon
    • Lead and support strategic projects related to Risk Management of the Novartis Vigilance System
  • Guidance and Training:
    • Prepare and maintain guidance documents and training material to educate Patient Safety associates on the Quality Issue & Quality Event process
  • Compliance and Metrics:
    • Monitor compliance of the Patient Safety organization to Quality Issue & Quality Event handling processes and standards
    • Develop and implement strategies to address deficiencies
    • Collaborate with Compliance, Process Excellence, QPPV Office, and other functions to produce metrics and complete trend analyses
  • Collaboration and Leadership:
    • Collaborate with Global Line Functions across Novartis Divisions and Third Parties to establish and meet joint accountabilities
    • Lead the development and maintenance of procedural documents, including ownership of relevant PSMF sections and annexes
    • Act as a subject matter expert during audits and inspections, leading the preparation of responses to findings and the development and implementation of corrective and preventative actions
  • Reporting and Escalation:
    • Prepare reports and/or presentations to document the outcome of risk assessments for the Process Governance and Risk Mitigation management team
    • Escalate key findings to the Head Compliance and Risk Management and/or relevant governance or LT board
  • Operational Metrics & Risk Committee:
    • Support the management of the Operational Metrics & Risk Committee as the Secretary, scheduling meetings, preparing agendas, and tracking and following up on actions

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

Educational Background:

PharmD, MSc Degree in Life Sciences or equivalent

Languages:

Why Advanced Accelerator Applications (Italy) - S.p.A.?

We believe new insights, perspectives, and groundbreaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable, and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity, and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges. Because the greatest risk in life, is the risk of never trying Imagine what you could achieve here at Advanced Accelerator Applications (Italy) - S.p.A.

Commitment to Diversity & Inclusion:

Advanced Accelerator Applications (Italy) - S.p.A. is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.


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