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