As a Medical Safety Lead, you will collaborate closely with the Global Program Safety Lead (GPSL) to provide expert safety evaluation and drive medical innovation. Your role is to ensure patient safety across the product lifecycle, integrating and analyzing both internal and external safety information to enhance Novartis's impact on patient outcomes.
In this role, you'll have the opportunity to work cross-functionally, leveraging your expertise to improve patient safety and contribute to Novartis's goals. Your responsibilities include monitoring clinical safety, evaluating safety signals, and providing medical inputs for regulatory and clinical documents.
Safety Monitoring: Oversee the clinical safety of projects/products, including literature reviews, individual case evaluations, and signal detection. Address safety-related queries promptly and appropriately.
Medical Assessment: Conduct medical assessments for single cases, including follow-up information collection, evaluation of product quality defects with adverse events, and preparation of investigator notifications and ethics committee reports.
Signal Detection: Identify and evaluate safety signals based on single cases and aggregate data using appropriate tools.
Regulatory and Legal Support: Provide medical input for responses to regulatory inquiries, health care professionals, and legal queries. Prepare safety data for Health Authority review and contribute to safety documents.
Documentation and Reporting: Assist in the preparation of safety documents such as core data sheets and clinical safety summaries. Contribute to the Safety Profiling Plan (SPP) and Risk Management Plan (RMP) updates.
Cross-Functional Collaboration: Work with Clinical Development, Regulatory Affairs, Medical Affairs, and other departments to provide safety inputs for clinical and regulatory deliverables.
Project Support: Support licensing activities, regulatory inspections, and project/product recall activities as needed.
Novartis touched 766 million lives with its medicines in 2021, and we are committed to doing even more. We believe in finding innovative solutions at the intersection of medical science and digital innovation. Our diverse, equitable, and inclusive environment fosters creativity and collaboration, driving us to tackle the world’s toughest medical challenges.
Join us and be part of a community that supports and inspires each other to achieve breakthroughs that change patients' lives. Imagine the possibilities at Novartis!
If this role doesn’t fit your experience or career goals but you want to stay connected, join the Novartis Network to learn about future opportunities.
For more details on how Novartis supports a culture of integrity, curiosity, and flexibility, visit Novartis People and Culture.
Andra Pradesh :
Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Mangalagiri | Tirupathi | Visakhapatnam |Assam :
Dibrugarh | Diburghar | Guwahati |Bihar :
Hajipur | Patna |Chhattisgarh :
Bilaspur | Raipur |Delhi :
Delhi | India | New Delhi | PAN-India |Goa :
Goa | Panaji |Gujarat :
Ahmedabad | Baroda | Gandhinagar | Mehsana | Tarasadi | Vadodara | Vapi |Haryana :
Ambala | Hisar | Kurukshetra | Panchkula | Rohtak |Himachal Pradesh :
Solan |Jharkhand :
Ranchi |Karnataka :
B.G Nagara | Bangalore | Belgaum | Bengaluru | Mangaluru | Mysore | Udupi |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram |Madhya Pradesh :
Dewas | Gwalior | Indore |Maharashtra :
Ambernath | Amravati | Aurangabad | Jalgaon | Kolhapur | Mumbai | Nagpur | Navi Mumbai | Pune | Pune city | Shirpur | Tarapur | Thane |PAN-India :
Panjab :
Punjab :
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 :
Dehradun | Nainital | Rishikesh |West Bengal :
Kolkata | Mukundapur |Arizona :
Chandler | Tempe | Tucson |California :
Brisbane | Davis | Emeryville | Foster City | Fremont | Irvine | La Jolla | Los Angeles | Mountain View | Nevada | Pasadena | Pleasanton | Riverside | Sacramento | San Bernardino | San Diego | San Francisco | San Gabriel | Santa Clara | Santa Monica | Simi Valley | Stanford | West Valley City |Colorado :
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Coral Gables | Gainesville | Jacksonville | Orlando | Rueil-Malmaison | Tallahassee | West Palm Beach |Georgia :
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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 :
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Gottingen | Hannover | Leipzig |Mecklenburg Vorpommern :
Rostock |Munich :
Bavaria |North Rhine Westphalia :
Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |Rhineland Palatinate :
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Hamburg |Saarland :
Saarbrucken |Saxony Anhalt :
Halle |Schleswig Holstein :
Kiel |New South Wales :
Sydney |Queensland :
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Nedlands |Republic of China :
Beijing |Tokiyo :
Osaka | Tokyo |Republic of Colombia :
Bogota |Zagreb :
Zagreb |Republic of Egypt :
Cairo |United Kingdom :
Salt Lake City | London |Republic of Ireland :
Limerick | Dublin |Republic of Korea :
Seoul |Capital of Netherland :
Amsterdam |Remote :
Switzerland | Remote, USA | Remote | Remote - Europe |Makkah :
Rabigh | Riyadh | Jeddah | Khulais | Najran |Catalonia :
Barcelona |Republic of Thailand :
Bangkok |