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      Senior Patient Safety Specialist

      REQ-10053842
      7月 08, 2025
      China

      摘要

      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 CPSH and/or PSGM.

      About the Role

      Key responsibilities:

      • Manage the collection, processing, documentation, reporting and follow-up of all adverse event reports for all Novartis products from Clinical Trials, Non-interventional Studies, Patient Oriented Program (POPs)s, Literature, Spontaneous Reports, and any other source of information.
      • Transcribe, translate, and enter data from source documents into safety systems accurately and consistently with focus quality and on timeliness. When case processing activities are externalized, liaise with the respective External Service Providers to ensure Novartis Procedures’ compliance.
      • Manage reporting/submission/distribution of safety reports/updates/information (e.g., SAE, SR, IN/SUSAR, PSUR, Biannual SUSAR Listing, DSUR) to Local Health Authorities (LHA) and/or clinical
        operations in cooperation with other Country Organization Departments.
      • 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.
      • Ensure compliance with the commitments disposed in the contracts/ agreements. Ensure the applicable local contracts/ agreements are tracked in the respective Pharmacovigilance Agreement SharePoint.Ensure any significant departure from the standard vigilance templates are communicated and endorsed by the global PS Alliance group.
      • Perform reconciliation with other departments (e.g., Medical Information, Quality Assurance, and Thirdparty contractors, as applicable) for potential AEs resulting from medical inquiries, quality related complaints and other sources.
      • Management and maintenance of all relevant local Patient Safety databases.
      • Ensure that relevant local literature articles are screened as appropriate.
      • Prepare and submit KPI reports on compliance in a timely manner including identification of rootcause(s) for late reporting to LHA, development and implementation of corrective action(s) as needed.
      • Develop and update training materials for vigilance and ensure training of Country Organization associateson 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 onboarding of new PS associates and mentor less experienced Patient Safety associates
        under close collaboration with the CPSH or PSGM
      • Other agreed tasks assigned by manager.

      Essential requirements:

      • Health Care Sciences Professional (e.g., Medical Doctor, Nurse, Pharmacist), life science degree or equivalent training and experience.
      • Fluent in both written and spoken English
      • Fluent in both written and spoken local language
      • Knowledge of national and international regulations for pharmacology
      • Knowledge of pharmacological and medical terminology
      • Project management skills
      • Computer skills
      • 2 years as Patient Safety Specialist (preferred)

      ​​

      Desirable requirements:

      • Good communication and interpersonal skills
      • Quality and results oriented

      Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? http://www.novartis.com/about/strategy/people-and-culture

      Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: http://talentnetwork.novartis.com/network

      Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: http://www.novartis.com/careers/benefits-rewards

      A female Novartis scientist wearing a white lab coat and glasses, smiles in front of laboratory equipment.
      REQ-10053842

      Senior Patient Safety Specialist

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