- Act as the contact point for local medical gases and medical devices safety issues within normal business hours.
If LVO holds the role as local QPPV, LVOs must be reachable 24 hours/day, 7 days/week.
- Implementing pharmacovigilance (PV) and medical device vigilance according to the local vigilance standard operating procedure which is developed based on the local and global vigilance requirement.
- Work with OS QRA in maintaining the local Vigilance system.
- Pharmacovigilance Processes
- Notifying Global Pharmacovigilance (PV) Management
- Quality Incident Management
- Reconciliation and self -assessment
- Public Adverse Event Reporting
- Agency Reporting
- Periodic Safety Update Reports
- Risk Management Plan
- Global Vigilance Audit by Global Assessment
- Third-Party Healthcare Contractors Vigilance Audit
- Inspection (Audit performed by authorities
Requirements
- At least 2 years in Pharma / Healthcare doing Quality /ISO /GMP
- University degree in a technical discipline (engineering preferred)
- Post-graduate development programs, e.g., quality systems, change management, problem solving tools, project management.
- Healthcare manufacturing processes and knowledge preferred.
- Excellent interpersonal and presentation skills in order to communicate effectively with customers and senior management.
Location: Jurong Island (100% onsite)
(The company transport picks up at lakeside MRT, morning 7.45am & 7.55am, evening 5.35pm & 5.45pm)
Working hours: 8.30am to 5.30pm (Mondays to Fridays); with 1-hour lunch break.
Salary: $4K to 5.5K max per month + 250 site allowance + 1.5 month completion bonus + 14 days AL + $600 medical + $1000 specialist per year
Interest applicants, pls email updated resume to
Jessie Hoe Huey Miin
CEI Reg No. R
EA Lic: 99C4599
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