The opportunity
Organize and coordinate Pharmacovigilance (PhV) activities in China, Taiwan and Hong Kong. Liaise with local markets and key functions (regulatory affairs, medical affairs, supply chain, quality assurance, marketing and legal) to make sure safety related information to company products is appropriately managed and communicated. Maintain PhV compliance, as per Teva corporate standards and applicable local regulations and to keep oversight on collection and reporting of adverse events and other safety related reports.Additionally, acting as the Qualified Person, you will need to ensure compliance with the local regulations and standards pertaining to PhV, communication of product safety information, preforming risk minimization activities in business collaboration and working with cross-functional departments, such as Medical, Regulatory Affairs, Legal and Quality.How you’ll spend your day
General PhV tasks
Acts as qualified person responsible (QPPVA) for PhV according to China, Taiwan and Hong Kong specific local requirements
Responsible to establish, maintain and keep oversight of a local PhV system in China, Taiwan and Hong Kong
Will act as the Local Safety Officer for both China, Taiwan and Hong Kong, and is a key interface between the country and the regional PhV team
Ensures compliance through local SOP/ WI development describing communication flow cross functionally and providing training thereof
Coordinates PhV activities with local distributors to make sure terms from PhV agreements are being followed
Aligns with regional PhV manager on business development activities in the country
Provides expert input to regional PhV management and Global PhV to ensure adherence to relevant local regulations
Works with medical affairs and marketing on local clinical trials, post marketing surveillance (PMS), market research, patient support programs organized in China, Taiwan and Hong Kong by providing PhV input for the contract with relevant vendors and for the workflows
Works with local business and RA to understand updates in product portfolio, MAH and communicates changes thereof to regional PhV management
Adverse Event Management and Communication
Manages collection and communication of adverse event reports and other safety information that ocurred in the territory
Makes sure relevant adverse event reports are submitted to the relevant authorities as per local requirements
CCSI Handling
Review of updated CCSI and confirm with RA/ manufacturer if changes in Local PIs are required
PSUR handling
Confirm if PSUR is required for products registered
Develop a local PSUR submission schedule
Translate and re-format PSUR (if required) and submit the National Health Authorities in China, Taiwan and Hong Kong, as per local requirements
RMP Handling
Aligns and cooperates with regional PhV team on preparation of the local RMP and discuss with local RA specific requirements by the National Health Authorities
Laises with the Local RA team to address additional requests from the Health Authorities in China, Taiwan and Hong Kong
Coordinates implementation of the Risk Management Plans (RMP) in China, Taiwan and Hong Kong
Regulatory compliance, audit and inspections
Monitors the progress with PhV legislation in the countries in cooperation with Local RA or other appropriate business partners
Assists in preparation of local PhV audit or inspection
Prepares and executes CAPAs related to PhV audits & inspection findings in the countries
System management
Ensures appropriate document repository is updated accordingly to correctly reflect changes in agreements, RMP, PSUR, ICSR i.e. Trackwise, Delta respectively
