To lead Patient Safety operational processes at the Country Organization ensuring compliance with Novartis global and local procedures, national and international regulations/ standards/ guidelines for vigilance of Novartis group approved, marketed and investigational products (incl. drugs, food supplements and medical devices).

Key responsibilities:

•Manage a team of PS Associates (such as PS Specialists, PS Senior Specialists and/or PS Managers) in line with the country PS organizational structure and PS strategy in place.

•Act as qualified delegate of the Local Qualified Person for Pharmacovigilance/ Local PV Responsible Person in Novartis Country Organization, as defined by local regulation and applicable legislation, in terms of ensuring compliance of adverse drug reactions monitoring and submission.

•Act as qualified delegate of the Country Patient Safety Head in terms of operational vigilance processes.

•Ensure robust oversight and compliance in terms of reporting/submission/distribution of safety reports/updates/information (e.g., SAE, SR, IN, SUSAR, PSUR, DSUR, changes in risk-benefit profile) to Local Health Authorities (LHA) according to regulatory requirements and Novartis procedures.

•Work in close collaboration with other local and global medical safety functions to ensure accurate evaluation of safety data.

•Interact and exchange relevant safety information with Health Authorities, other functional groups, third-party contractors, and PS associates, as applicable.

•Monitor national pharmacovigilance regulations and provide update to global PS organization.

•Set up, update, and implement local procedures to ensure compliance with PS global procedures and national requirements.

•Ensure local PS-related RMP commitments are executed and properly documented

•Provide scientific expertise during review of all Phase IV Clinical Trial and NIS protocols safety sections including Research Collaborations and if a Contract Research Organization (CRO) is conducting the trial or study, review safety relevant sections of the contract.

•Act as a key partner who provides input, during the process of establishing local programs (ex. POPs, DEAs

SM/SML, etc.): comments on proposals for vigilance language, content, and establishment of necessary controls on collection and reporting of adverse event information.

•Ensure that relevant local literature articles are screened, as appropriate.

•Supervision of management and maintenance of all relevant PS databases.

•Ensure timely preparation and submission of KPI reports on AE reporting and AE follow-up attempts including identification of root cause(s) e.g., for late reporting to HA, missed or delayed follow-up attempt, development and implementation of corrective and preventative action(s) as needed.

•Support in developing and updating training materials for pharmacovigilance and ensure training of Country Organization associates on relevant PS procedures for AE reporting, including field force and third-party contractor, if applicable.

•Ensure support for and close-out of audits, corrective action plan, investigation, and Health Authority inspections.

•Ensure selection, and recruitment of qualified PS team members and their further professional development.

•Ensure training and oversight of commissioned staff, as applicable.

•Contribute to the preparation and update of the local Pharmacovigilance System Master File as per regulation and related procedures.

•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 other languages (desirable)

•Leadership and (people-)management skills

•Excellent communications and negotiation (networking) skills

•Quality and results oriented

•Business mindset

•Computer skills

•3 years’ experience in pharmacovigilance or equivalent field

为什么选择诺华：帮助患者及家属不仅需要创新科学，还需要一支包括你我他在内的充满智慧与激情的团队，大家相互协作、支持与激励。共同实现突破，改变患者的生活。一起共创更好的未来，你准备好了吗？

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Safety Science

Pharmacovigilance

Databasing

Management Reporting

Employee Training

Waterfall Model