摘要
About the Role
Major accountabilities:
- To be the accountable for specific operational vigilance process(es) at the Country Organization
- To mentor less experienced staff, maintaining a professional network of key contacts and role model Novartis values and behaviors.
- Act as deputy of the Country Patient Safety Head, and operationally (in terms of management of the PS Team)
- Ensure oversight and compliance in terms of reporting/submission/distribution of safety reports/updates/information (e.g., SAE, SR, IN, SUSAR, PSUR, changes in risk-benefit profile) to TFDA according to regulatory requirements and Novartis procedures.
- Work in close collaboration other local and global medical safety functions to ensure accurate evaluation of safety data.
- Interact and exchange relevant safety information with TFDA, 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 all relevant PS databases.
- Ensure timely preparation and submission of KPI reports on AE reporting or AE follow-up 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.
- Other agreed tasks assigned by manager.
Key performance indicators:
- Organisation, quality management and efficiency of vigilance processes
- Country Organization AE reporting compliance
- Results of business review, quality review, audits and inspections
- Internal and external customer satisfaction
- Compliance with VA requirements
- Compliance with RMP commitments
- Efficiency in transfer of activities during acquisitions and divestments
Minimum Requirements:
Work Experience:
- At least 2 years experience in pharmacovigilance industry
- Strong knowledge of PV regulations and guidelines( eg. ICH, GPvP)
- Experience in health authority inspections or internal PV audit
- Hands-on experience in authoring and maintaining Risk Management Plans(RMPs)
- Demonstrated ability to work with clinical, regulatory, medical affairs , quality teams and commercial
- Experience leading safety-related projects or initiatives
- Ability to mentor junior staff or manage a small team is a plus
- Strong written and verbal communication in English
Skills:
- Excellent communications and negotiation (networking) skills
- Quality focused and results oriented
- In-depth knowledge of adverse event (AE) reporting, signal detection, and benefit-risk evaluation
- Ability to align safety operations with broader organizational goals and contribute to innovation and transformation strategies
- Experience applying AI or machine learning tools in pharmacovigilance workflows (e.g., automation, Microsoft Automate) is a plus
Languages :
- Fluent in both written and spoken English
- Fluent in both written and spoken Chinese
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? https://www.novartis.com/about/strategy/people-and-culture
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