Teva Pharmacovigilance Manager 

China, Guangdong Province, Panyu District 

37033726

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

• University Degree qualification (life sciences) or related disciplines in natural/science/health care or nursing/pharmacy degree
• Minimum 3 years of relevant experience, in a global multi-national company - Some regional experience will be advantageous
• Strong understanding and experience in PhV at a senior level in the China and Hong Kong market and acting as Locally Qualified Person
• Knowledge of ICH guidelines and other global guidelines
• Experience with global safety database

Director Pharmacovigilance

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