Based in Hong Kong, at our Asia Pacific Headquarters and reporting to the Vice President, QREM (Quality, Regulatory and Environment Management) Asia Pacific, this position will be responsible for providing accurate & timely processing and management of product safety activities in compliance to both company policies and external regulations (medical device & drug).
Key Areas of Responsibilities:
- Upon adverse events and incidents, be accountable for collection, review, processing and preparation of notifications to authorities relating to AE/incidents or risk associated with our products
- Supervise the country product safety activities via close monitoring & interaction with local product safety associates, ensuring understanding & compliance at local level. Follow up to request additional information with particular adherence to internal & external time line for reporting
- Supervise post approval compliance activities: PSUR, PMSS, Literature Screening and other safety related data submission according to approval requirements, support inquiry from national authority
- Develop, review, update and provide training on SOP for product vigilance according to internal and external requirements.
- Prepare and facilitate Field Safety Corrective Action (FSCA)/ Product Recalls activities: call for Decision Council meetings, prepare notification/related documentations for execution by countries, communication with authorities & coordination with local countries of required actions related to recall. Closely partner with Corporate Product Safety to ensure Product Safety Compliance
- Collaborate with Medical Affairs on safety aspects of product safety review
- Review, implement & update Safety Data Exchange Agreement and related documents according to manufacturer’s requirements and national regulation
- Train & manage product safety personnel in the region on current & new regulatory requirements on product safety as appropriate
- Maintain knowledge of product safety reporting requirements & process. Stay breast of changes in regulations which may have impact and contribute to development, improvement & standardizations of new processes & methods.
- Act as deputy regional safety officer
Qualifications, Experience and Characteristics Required:
- Bachelor or Master Degree in Engineering/ Science or related field
- Minimum of 6 to 8 years pharmaceutical and medical device experience relating to pharmacovigilance and medical device vigilance. Working knowledge in QA/QC, quality and risk management system related to pharmaceuticals, medical device is an advantage
- Good knowledge of global regulations and compliance to safety of devices and drugs
- Ability to prioritize multiple projects and tasks
- Ability to work independently with methodical planning and problem solving skills as well as attention for details
- Good English, literacy in another Asia language is a definite advantage
- Ability to main confidentiality of product safety information
- There will be some travel according to project requirements
- Ability to apply multidisciplinary knowledge and to effectively collaborate within & cross functionally.
Please submit your CV with current and expected salary if you are interested.
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