Job title: Patient Safety Senior Specialist- 2 years fixed term contract
Company: Novartis
Location: Budapest
Job Description: Job Description Summary To support management of Patient Safety operational processes at Country Organization ensuring compliance with Novartis global and local procedures, national and international regulations/ standards/ guidelines for vigilance of both marketed and investigational products (incl. drugs, food supplements and medical devices) from Novartis Group.
To mentor less experienced Patient Safety associates through Patient Safety processes, systems, and operations. To support the implementation of local projects/ initiatives under close collaboration with the Cluster Patient Safety Head and/ or Patient Safety Group Manager.Job DescriptionMajor accountabilities:Develop, update, and implement local procedures to ensure compliance with Patient Safety global procedures and national requirements.Interact and collaborate with other departments (such as Medical Affairs, Marketing, Patient Engagement, etc.) to ensure that any projects/ initiatives involving safety data collection (POPs, DEAs, SM/SML, etc.) follow the Novartis vigilance requirements.Management and distribution of vigilance clauses to other departments (such as Legal, Procurement, etc.) to be included in local agreements if necessary.Advice the owners of local contracts/ agreements with impact in the vigilance system, about the vigilance provisions to be included, as required per Novartis procedures and/or applicable regulations.Develop and update training materials for vigilance and ensure training of Country Organization associates on relevant Patient Safety procedures for AE reporting, including field force and third-party contractors, as applicable.Ensure support to the internal audits, LHA inspections and implementation of the respective CAPA plan.Support the on-boarding of new PS associates and mentor less experienced Patient Safety associates under close collaboration with the Cluster Patient Safety Head or Patient Safety Group Manager.Minimum Requirements:Scientific degree (preferably Medical Doctor, Nurse, Pharmacist) or / and 2+ years experience on similar position.Knowledge of national and international regulations for pharmacovigilanceKnowledge of pharmacological and medical terminologyGood communication and interpersonal skillsQuality and results orientedProject management skillsComputer skillsWhy Novartis ?Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here:
Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams‘ representative of the patients and communities we serve.
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:Skills Desired Databases, Employee Training, Filing Documents, Pharmacovigilance, Reporting, Safety Science
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