Safety labeling manager cds&sd

Novartis pharma gmbh

• Holzkirchen

neues Angebot (20/05/2020)

stellenbeschreibung

Job Description 3000! That's how many safety signals have been detected and medically evaluated in one year, requiring 300 Core Data Sheet reviews and update packages. In Patient Safety, our mission is to improve patients' lives through maximizing the benefit-risk profile of our products. You can contribute to our mission as corporate safety healthcare professional for Core Data Sheet and Signal Detection where you will systematically detect and evaluate Safety Signals for assigned products. Would you like to work for a Global Generics and Biosimilars company and contribute to our mission to extend and improve people's lives? Join Sandoz! A division of Novartis, Sandoz is a global leader in Generic and Biosimilar medicines, committed to playing a leading role in driving access to medicine worldwide

Your Responsibilities

:

your responsibilities include, but not limited to:

• performs tasks assigned as per applicable procedures (e. g., gops, sops, wis), including tasks assigned in harmonized gops/sops/wis as per the role mapping in the applicable role matrix. - provides timely and adequate updates of the core safety information, supported by expert statements and commented track change versions of the core data sheet. - prepares data packages required by 3rd party providers. reviews and qualifies core data sheets deliveries from providers;

creates new ones as needed. - ensures patient safety through timely and adequate updates of the core safety information of marketed products. - tracks signals in the signal management tracking system, and evaluates line listings and safety information in scientific literature, including reference product information and regulatory authority communication. - presents safety issues to the safety management board and other internal boards as needed. - supports in training and development of new colleagues who are supporting the core data sheet team. minimum requirements what you'll bring to the role:

• health-care professional - physician or pharmacist - fluent english in writing and speaking - at least 4 years pv or label experience and regulatory - considers ha + internal stakeholder input appropriately desirable requirements:
• health-care professional with md, phd you'll receive:

(optional) competitive salary;
performance based annual bonus;
work/life integration;
eligible to sandoz pension plan;
30 working days' holiday per calendar year;
subsidised on-site cafeteria;
free shuttle bus between sandoz and holzkirchen train station;
additional benefits. why consider sandoz? our number 1 priority is to pioneer patient access to better healthcare. we are a company of firsts. 1st to develop an oral penicillin antibiotic. 1st to develop and launch biosimilars. 1st to launch an fda-cleared digital therapeutic. and we never stop asking:

how can we continue to pioneer access in an ever-more digital and global world? the answers come when curious, courageous and collaborative people are empowered to ask new questions, make bold decisions and take smart risks. sandoz, a novartis division, is a leader in generic and biosimilar medicines and a pioneer in digital therapeutics. imagine what you could do at sandoz! commitment to diversity & inclusion:

sandoz, a novartis company, embraces diversity, equal opportunity and inclusion. we are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential. hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability. 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:

division global drug development business unit cmo & patient safety gdd location deutschland site holzkirchen (bei münchen) company/legal entity sandoz international functional area forschung & entwicklung job type vollzeit employment type unbefristet shift work nein

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