As a leader in pharmacovigilance and device vigilance, you will oversee the end-to-end management of vigilance processes at Novartis. Your role involves leading cross-functional and transformative projects to ensure global regulatory compliance while optimizing efficiency and streamlining processes.
You will be responsible for managing high-complexity vigilance processes, driving continuous improvement, and leading critical projects. Your role includes ensuring compliance with emerging regulations, optimizing processes, and acting as a subject matter expert in pharmacovigilance.
Process Optimization: Lead efforts to streamline and automate vigilance processes by collaborating with global and local stakeholders. Identify and implement opportunities for process improvement.
Project Leadership: Manage complex cross-functional and PS&PV projects, including IT systems and high-priority initiatives. Act as the process owner for critical vigilance processes within your functional area.
Regulatory Compliance: Monitor emerging regulations, assess their impact, and drive necessary process changes to maintain compliance. Analyze how Novartis processes and organizational changes affect assigned vigilance processes.
Documentation and Training: Develop, communicate, and maintain procedural documents and training materials. Work with other functions to establish metrics trend analyses and address any identified risks.
Subject Matter Expertise: Provide expert guidance on regulatory requirements and business processes to PS&PV associates, Country Organizations, and other Global Line Functions. Maintain relevant sections of the Pharmacovigilance System Master File (PSMF) and Business Continuity Plans.
Safety Database Enhancements: Lead the development and implementation of safety database improvements and new case processing conventions. Collaborate with stakeholders on data migration and regulatory changes.
Audit and Inspection: Act as a subject matter expert during audits and inspections (e.g., EMA, FDA). Prepare responses to findings and develop corrective and preventative actions in line with company strategy.
Collaboration and Representation: Work with global and third-party stakeholders to meet joint accountabilities. Represent Novartis in governance boards, cross-functional forums, and external conferences as a subject matter expert.
At Novartis, we touched 766 million lives with our medicines in 2021, and we're committed to doing even more. We believe groundbreaking solutions arise at the intersection of medical science and digital innovation. Our diverse, equitable, and inclusive environment fosters creativity and collaboration.
We thrive in an unbossed culture driven by integrity, curiosity, and flexibility. By working together with courage, we tackle the world’s toughest medical challenges and reinvent what’s possible. Join us in our mission to make a global impact!
If this role doesn’t align with your experience or career goals but you want to stay connected, join the Novartis Network to learn about future opportunities.
For more information on our culture and career opportunities, visit Novartis People and Culture.
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Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Mangalagiri | Tirupathi | Visakhapatnam |Assam :
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Solan |Jharkhand :
Ranchi |Karnataka :
B.G Nagara | Bangalore | Belgaum | Bengaluru | Mangaluru | Mysore | Udupi |Kerala :
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Bathinda | Bela | Chandigarh | Moga | Mohali | Patiala | Phagwara | Rajpura |Rajasthan :
Banasthali | Jaipur | Pilani | Udaipur |Tamil Nadu :
Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | Srivilliputtur | Tiruchirappalli | Trichy |Uttar Pradesh :
Gajraula | Gautam buddha Nagar | Ghaziabad | Greater Noida | Jhansi | Lucknow | Mathura | Noida | Park City | Prayagraj | Varanasi |Uttarakhand :
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Chandler | Tempe | Tucson |California :
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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 :
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Mexico |Tennessee :
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Blacksburg | Charlottesville | Falls Church |Washington :
Pullman | Seattle |WI :
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Baden-Wurttemberg :
Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen |Bavaria :
Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Berlin :
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Zagreb |Republic of Egypt :
Cairo |United Kingdom :
Salt Lake City | London |Republic of Ireland :
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Seoul |Capital of Netherland :
Amsterdam |Remote :
Switzerland | Remote | Remote - Europe | Remote, USA |Makkah :
Rabigh | Riyadh | Jeddah | Khulais | Najran |Catalonia :
Barcelona |Republic of Thailand :
Bangkok |