Job Description

Who we are

Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

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

Your experience and qualifications

• 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

Make a difference with Teva Pharmaceuticals

Please submit your CV and a cover letter responding to the selection criteria outlining relative keys skills and experience in relation to this role

Please note that only shortlisted candidates will be contacted

Reports To

Director Pharmacovigilance

Already Working @TEVA?

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Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.

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