Pharmacovigilance Manager

Date: Jun 3, 2025

Location:

Shanghai Shi, China, 200040

Company: Teva Pharmaceuticals

Job Id: 62292

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

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