Summary
The role involves developing and implementing new monitoring activities and metrics for safety case management, aggregate reporting, and risk management plan processes. This includes assessing and adapting established metrics in response to regulatory and environmental changes within Novartis. The role also oversees the completion of monitoring activities and the production of metrics.
About the Role
Major Accountabilities:
Metrics Development and Implementation: Collaborate with process/metrics owners, Quality Assurance (QA), and other global functions to develop and maintain compliance and quality metrics. This includes creating tools in partnership with Innovation, Tech & Systems, and other Global Line Functions to monitor compliance and quality, with a focus on automation.
Training and Communication: Develop and implement training materials and communications to support the understanding and use of metrics.
Regulatory Compliance: Monitor emerging global regulations, perform impact assessments, and drive necessary process changes to ensure compliance with global regulatory requirements. Ensure timely implementation of changes required by new regulations or health authority guidance.
Documentation and Feedback Integration: Lead the development and maintenance of procedural documents, including ownership of relevant PSMF sections and annexes. Review and integrate feedback from Health Authorities and external parties into Novartis standards as needed.
Audit and Inspection Support: Act as a subject matter expert during audits and inspections (e.g., FDA and EMA), lead response preparations, and develop corrective and preventative actions (CAPAs).
Monitoring and Reporting: Oversee assigned monitoring activities and metric production. Lead investigations into deficiencies, develop CAPAs, and measure their effectiveness.
Collaboration and Risk Management: Work with other Global Line Functions and Third Parties to meet joint accountabilities. Escalate risks identified through metrics data analysis to the Operational Metrics and Risk Committee and relevant stakeholders.
External Representation and Mentorship: Represent Novartis externally as a subject matter expert and support the sharing of best practices. Mentor associates to enhance their understanding of compliance and quality metrics.
Mergers and Acquisitions: Act as a business representative during mergers and acquisitions, providing expertise and support.
Training and Mentorship: Train and mentor new PS&PV associates and associates from other global functions.
Minimum Requirements:
Why Novartis?
Novartis is committed to improving and extending people's lives, touching 766 million lives in 2021. We believe that new insights and groundbreaking solutions can be found at the intersection of medical science and digital innovation. Our diverse, equitable, and inclusive environment inspires new ways of working. We thrive in an unbossed culture that fosters integrity, curiosity, and flexibility, encouraging us to tackle the world's toughest medical challenges. Join us to create a brighter future together.
Join our Novartis Network:
If this role does not match your experience or career goals, you can still connect with us to stay informed about future opportunities by joining the Novartis Network.
Why Novartis: Our mission goes beyond innovative science; it requires a community of smart, passionate people collaborating and supporting each other to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? Learn more here
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Punjab :
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Atlanta |Hawaii :
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Abbott Park | Champaign | Chicago | Deerfield | Lombard | Naperville |Indiana :
Bloomington | West Lafayette |Kansas :
Lawrence |Maryland :
Baltimore | Rockville |Massachusetts :
Boston | Cambridge | Medford and Somerville | Rockland |Minnesota :
Minneapolis and St. Paul, Minnesota. |Missouri :
Fulton | St. Louis |New Jersey :
Basking Ridge | Bloomfield | Branchburg Township | Bridgewater | Brunswick | Burlington | Charlotte | Clark | Cranbury | East Brunswick | Edison | Fairfield | Far Hills | Flemington | Hackensack | Indianapolis | Linden | Livingston | Lyndhurst | Mahwah | Monmouth Junction | Mount Arlington | New Brunswick | Newark | Nutley | Paramus | Parsippany | Passaic | Paterson | Peapack-Gladstone | Pine Brook | Piscataway Township | Plainsboro | Princeton Junction | Rahway | Raritan | Somerset | Somerville | South Plainfield | Sparta | Summit | Titusville | Trenton | Warren Grove | West Orange | Westfield | Wharton | Whippany |New York :
Biddle | Buffalo | Ithaca | Morningside Heights | New York | Syracuse |North Caroline :
Chapel Hills | Durham | Morrisville | Raleigh | Scottsdale |Ohio :
Columbus, |Pennsylvania :
Ambler | Philadelphia | Pittsburgh |Puerto Rico :
San Juan |Republic of Mexico :
Mexico |Tennessee :
Nashville |Texas :
Austin | Dallas | Houston | Richardson |Virginia :
Blacksburg | Charlottesville | Falls Church |Washington :
Pullman | Seattle |WI :
Madison | Wausau |Wisconsin :
Baden-Wurttemberg :
Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen |Bavaria :
Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Berlin :
Mitte |Brandenburg :
Berlin |Hesse :
Marburg |Hessen :
Frankfurt |Lower Saxony :
Gottingen | Hannover | Leipzig |Mecklenburg Vorpommern :
Rostock |Munich :
Bavaria |North Rhine Westphalia :
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Saarbrucken |Saxony Anhalt :
Halle |Schleswig Holstein :
Kiel |New South Wales :
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Tokyo | Osaka |Republic of Colombia :
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Zagreb |Republic of Egypt :
Cairo |United Kingdom :
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Limerick | Dublin |Republic of Korea :
Seoul |Capital of Netherland :
Amsterdam |Remote :
Remote, USA | Switzerland | Remote - Europe | Remote |Makkah :
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Barcelona |Republic of Thailand :
Bangkok |