• 招聘类型：社招
• 工作性质：全职

职位描述

1) Complaint & Adverse Event Intake monitoring 40%

Oversee the 1st line complaint handling process performed by a 3rd party vendor to ensure that all medical and non-medical complaints associated with the Allergan medical devices are entered in Trackwise in accordance with company’s SOPs. Transfer any incoming complaints to the 3rd party vendor to ensure timely logging. Liaise closely with in-country Allergan contacts (sales representatives e.g.) for support to 3rd party vendor. Attend regular review meetings with 3rd party vendor. All the above tasks are to be carried out in compliance with the timeline metrics associated with the activities.

2) Vigilance reporting 40%

Ensure all incidents (domestic and oversea) that require regulatory reporting to the China health authority are reported in accordance with the regulatory requirements. Report information to QA/RA/PV personnel as necessary. Communicate to Product Surveillance management requests from the China health authorities and lead their responses until timely submission.

3) Complaint Device Management 10%

Send out explant kits as required to complainants, distributors and relevant in-country Allergan contacts. Log incoming returned devices and update TrackWise records accordingly. Manage the weekly bulk shipment of devices to the analytical laboratory at Allergan site(s).

5) Quality System Administration 10%

Perform administrative tasks related to Quality System documentation for Allergan Medical Quality System. These tasks include, but are not limited to, maintaining own training file, maintaining and archiving documents related to customer complaints, adverse events, vigilance reports and correspondence with Competent Authorities and maintaining deviation and corrective and preventative action records.

Develops and maintains local SOPs/DOPs, related to medical device complaint handling, that follow local regulations and that are in accordance with corporate SOPs.

CONTACTS

• Complainants
• Country RA/QA/PV personnel
• Country Medical Reps
• Department Managers
• US Product Surveillance Department
• Inter-departmental Personnel
• Manufacturing site personnel

任职条件

Education and Experience:

• Bachelor’s degree with major in Life Science is preferred
• Experience in the healthcare, medical device or pharmaceutical industry
• Ability to comply with clearly defined Standard Operating Procedures
• Ability to comply with Good Documentation practices applicable to Pharmaceutical/Medical Device requirements.

Knowledge:

• Good understanding of local technovigilance regulations and guidance.
• Awareness of Good Documentation practices applicable to Medical Device regulatory requirements would be an advantage.
• Awareness of all applicable regulatory requirements would be an advantage:

o FDA’s 21 CFR Part 820 (Quality System Regulation), 21 CFR Part 803 (MDR Regulation) and 21 CFR Part 11 (Electronic Records; Electronic Signatures).

o ISO 13485

Competencies and Skills:

• Fluent English (spoken and written) is required.
• Ability to demonstrate a logical and analytical approach, with focus on attention to detail.
• Ability to comply with quality systems procedure and policies.
• Ability to communicate effectively, orally and in writing, with employees of various disciplines and all other internal and external contacts.
• Ability to work independently, take initiative and make decisions within department/company guidelines.
• Able to work effectively in a team/matrix environment.
• Able to collaborate effectively across cultural, language and time zone barriers.
• Proficiency in the use of Microsoft Word, Excel and PowerPoint. TrackWise experience would be highly desirable.

职位要求

• 学历要求：无
• 工作经验：无
• 外语要求：不需要

公司福利

• 弹性工作制度 
• 健全的医疗保障 
• 短期/长期激励计划 
• 员工推荐计划 
• 弹性福利