Jurong Island
(The company transport picks up at lakeside MRT, morning 7.45am & 7.55am, evening 5.35pm & 5.45pm)
8.30am to 5.30pm (Mondays to Fridays); with 1-hour lunch break.
Salary Range: $4K to $5.5K basic + $250 site allowance + 1.5 month completion bonus + 14 days AL + $600 medical + $1000 specialist per year
Responsibilities
Act as the Local Vigilance Officer (LVO) responsible for implementing and maintaining vigilance processes for medical gases and medical devices, in line with regulatory and internal quality requirements.
Serve as the local contact point for product safety issues and ensure timely reporting of adverse events and medical device incidents to relevant authorities.
Ensure product release to market is carried out in compliance with quality and safety standards.
Support the maintenance and continuous improvement of the Quality Management System (QMS).
Lead or assist in quality investigations and corrective/preventive actions (CAPA).
Conduct and track vigilance training for internal staff and third-party partners.
Monitor local regulations, authority websites, and scientific literature for new safety information.
Prepare and submit safety reports, including Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs), when required.
Coordinate with global and regional teams on pharmacovigilance (PV) and medical device vigilance matters.
Support internal and external audits or inspections related to product vigilance and quality compliance.
Requirements
Min Degree in Engineering, Life Sciences, Pharmacy, or a related technical discipline.
We regret that only shortlisted candidates will be notified.
#J-18808-Ljbffr