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 Implementation and maintenance of product safety systems for drugs and medical device in Asia region according to Company’s requirements and in compliance with regulations in each country. The role is to provide accurate, timely post market product safety activities including, but not limited to, assessing, preparing and reporting notification to health authority, coordinating recalls, maintaining related records and prepare routine reports.

Key Areas of Responsibilities:

• Coordinate with each country in processing of adverse events, incidents, other safety information, preparation of notifications to authorities relating to AE/incidents or other product’s risk associated with Company’s products. Timely follow up
• Supervise the country product safety activities via close monitoring & interaction with local product safety persons. Timely follow up on requesting additional information, paying attention to meeting internal & external time line for reporting
• Ensure post approval compliance activities are met: PSUR, PMSS, Literature Screening and other safety related data submissions required by health authority in each country
• Ensure understanding & compliance to Company’s product safety procedures at country level. Support review and roll out of SOP for product safety according to Company’s requirements.  Maintain training records
• 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 partners with Corporate Product Safety to ensure Product Safety Compliance
• Collaborate with Medical Affairs and support on medical review
• Review, implement & update Safety Data Exchange agreement, pharmacovigilance agreements  and any other related documents according to Company’s requirements and national regulations
• Maintain knowledge of product safety reporting requirements & process.  Stay breast with changes in regulations which may have impact and contribute to development, improvement & standardizations of new processes & methods
• Act as Product Safety Responsible Person - e.g. Regional Safety Officer (medical device), Pharmacovigilance Responsible Person(drugs)
• Handle ad-hoc product safety assignments from manager as required

Qualifications, Experience and Characteristics Required:

• Bachelor or Master Degree in Engineering/ Science or related field 
• Minimum of 5 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
• Good  communication skills in both written and verbal English and Chinese. Skills in verbal Mandarin or other Asian languages would be a plus
• A team player with good interpersonal skills to communicate across different cultures
• Ability to work independently with methodical planning and problem solving skills as well as attention for details
• Must be flexible and able to prioritize according to departmental needs
• Ability to utilize computer applications packages, such as MS Word, Excel, PowerPoint, Adobe Acrobat, maintain website pages etc.

Please submit your CV with current and expected salary if you are interested.

(Data collected will be used for recruitment purposes only. Candidates should consider their applications unsuccessful if not invited for interview within six weeks.)

Fresenius Medical Care– the world’s leading provider of products and services for people with chronic kidney failure in around 150 countries. We care for more than 320,000 patients in our global network of more than 3,700 dialysis clinics.

Creating a Future Worth Living. For Patients. Worldwide. Every Day.

We are listed on Frankfurt Stock Exchange and New York Stock Exchange and is included in DAX German market index since 1999.