346448BR
28. Juni 2022
Spain

Job Description

769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives. We believe new insights, perspectives and ground-breaking 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.

As Senior Risk Management Manager you will lead activities and initiatives designed to identify and categorize risks that potentially impact the Vigilance system and the broader CMO&PS organization as well as the prepare action plans for CMO&PS leadership endorsement. Ensure oversight of management of Patient Safety deviations and quality incidents in AQWA.

Your responsibilities include, but not limited to:

• Drive the development of actionable insights and mitigation plans to ensure that any opportunities for improvement are identified and acted upon as early as possible.
• Lead and support strategic projects related to Risk Management of the Novartis Vigilance System.
• Prepare/maintain guidance documents and training material to educate Patient Safety associates on the deviation and quality incident process.
• Monitor compliance of the Patient Safety organization to deviation and quality incident handling processes and standards and where deficiencies are identified, develop and implement strategies to address these.
• 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.
• 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.
• Prepare reports and/or presentations to document the outcome of risk assessments for the Process Governance and Risk Mitigation management team and escalate key findings to the Head Compliance and Risk Management and/or relevant governance or LT board.
• Prepare action plans based on the results of risk assessments, coordinating with other groups within CMO&PS and cross functionally as required.

Diversity & Inclusion / EEO

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

Minimum Requirements

What you’ll bring to the role:

• PharmD, MSc degree in life sciences or equivalent.
• At least 7 years of experience in the pharmaceutical industry, particularly pharmacovigilance.
• Experience in project management and demonstrated ability to lead work groups in a matrix.
• Solid working knowledge of PV regulations and systems.
• Strong organizational and negotiation skills.
• Excellent analyitical skills and ability to communicate and operate effectively in an international environment and across functions.
• Languages: Fluency in English. Spanish is valued, but not obligatory.
• Ability to mentor and coach

You’ll receive:

Competitive salary, annual bonus, pension scheme, health insurance, flexible working arrangements, subsidized dining facilities, employee recognition scheme.

Why consider Novartis?

769 million. That’s how many lives our products touched in 2020. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

Imagine what you could do at Novartis!

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Global Drug Development
CMO & PATIENT SAFETY GDD
Spain
Barcelona Gran Vía
Human Resources
Full Time
Regular
No
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346448BR

Senior Risk Management Manager

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