Based in Hong Kong, at our Asia Pacific Headquarters and reporting to the Product Safety Manager / Senior Manager, 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:
- Collect and conduct initial review & processing of adverse events, incidents and other safety information. Record and update product safety information into company’s electronic system meeting internal & external timelines
- Communicate & distribute product safety information to ensure timely reporting to meet internal & external regulatory timelines
- Monitor and screen product safety reports, ensure product safety issues are identified at early stage with timely follow up, requesting additional information from production sites, countries and other sources for risk assessment. Paying attention to internal & external timeline for reporting. Maintain product safety data record to comply with internal and external requirements & prepare routine reports
- Coordinate with countries regarding post approval compliance activities: PSUR, PMSS, Literature Screening and other safety related data submission according to approval requirements, support inquiry from national authority
- Assist in SOP development/update and training for product vigilance according to internal and external requirements. Maintaining training records
- Assist in Field Safety Corrective Action (FSCA) / Product Recalls activities such as meeting minutes, prepare notification/related documentations, follow up with countries on communication with authorities & coordination with required actions related to recall. Maintain records of FSCA/Product Recalls notifications and related documents
- Provide input in update of Safety Data Exchange Agreements and related documents according to manufacturer’s requirements and national regulation. Maintain records
- Stay abreast of changes in regulations which may impact to product safety activities and responsibilities, initiate update of SOP, agreements and other related processes where appropriate
- Act as deputy to supervisor in safety related reporting
Qualifications, Experience and Characteristics Required:
- Bachelor or Master Degree in Engineering/ Science or related field
- Minimum of 2-3 years in quality system management with practical experience in QA/QC with solid knowledge in regulations and standards applicable to pharmaceutical/medical device, food or chemical industry
- An understanding of regulations relevant to safety of devices and drugs would be an advantage
- Ability to work independently with methodical planning and problem solving skills as well as attention to details
- Ability to prioritize multiple projects and tasks
- 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
Please submit your CV with current and expected salary, and availability if you are interested.
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