345472BR
May 18, 2022
India

Job Description

769 million lives were touched by Novartis medicines 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.

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 do here at Novartis!

Reporting to the Head of Compliance & Risk Management and interacting across CMO&PS, the Senior Risk Management Manager will serve as a key driver for the operational risk management framework within CMO&PS. This position is accountable for leveraging PV Quality Management Systems tools and data to ensure governance and oversight of key risks across the Vigilance system. The Senior Risk Management Manager ensures that a proactive approach is taken for quality issues, process/system related risks, trending of data to identify risks, and predicts compliance risk to avoid reputational risk. The incumbent will coordinate and work alongside Leaders within CMO&PS as well as beyond to drive the CMO&PS risk management strategy worldwide, providing oversight and guidance to key projects and ensures remediation activities are undertaken and implemented at all affected sites and functions, while verifying effectiveness.

Your responsibilities include, but are 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 crafted 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
• Leading the development and maintenance of respective procedural documents including ownership of relevant PSMF sections and annexes.
• Train and mentor CMO&PS associates as well as associates from other line functions as needed on the deviation and incident management process as well as risk identification and mitigation strategies.
• Alert the Head Compliance and Risk Management to potential compliance issues. Participate and/or join external conferences and networks for respective area of expertise

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

• Minimum 7 years of experience in the pharmaceutical industry, particularly pharmacovigilance.
• PharmD, MSc degree in life sciences or equivalent.
• Experience in project management and demonstrated ability to lead work groups in a matrix
• Ability to deal and interact with a wide variety of people at all levels.
• Strong organizational skills; 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

Why Novartis?

766 million lives were touched by Novartis medicines in 2021, 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.
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 do here 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 hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Global Drug Development
CMO & PATIENT SAFETY GDD
India
Hyderabad, AP
Research & Development
Full Time
Regular
No
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345472BR

Senior Risk Management Manager

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