Location:
Jurong Island (Company transport picks up at lakeside MRT, morning 7.45am & 7.55am, evening 5.35pm & 5.45pm)
Duration:
1 year contract
Working Hours:
8.30am to 5.30pm (Mondays to Fridays); with 1-hour lunch break.
Salary:
Up to 5.5K max per month + 250 site allowance + 1.5 month completion bonus + 14 days AL + $600 medical + $1000 specialist per year
Job Responsibilities:
Safety Monitoring & Reporting:
Report and follow up on
adverse events
and
medical device incidents .
Conduct
literature searches
and monitor regulatory and media sources for safety signals.
Maintain compliance with
pharmacovigilance (PV)
and
medical device vigilance
requirements.
Regulatory Compliance & Communication:
Notify
Global PV Management
of safety cases, regulatory changes, or inspection findings.
Submit
Periodic Safety Update Reports (PSURs) ,
Risk Management Plans (RMPs) , and other required documents to authorities.
Ensure
local product information
aligns with safety and risk management commitments.
Training & Documentation:
Maintain LVO training records and deliver PV training to local staff and third-party partners.
Ensure proper documentation of cases, reports, and authorizations.
Third-Party & Quality Oversight:
Manage and review
Safety Data Exchange Agreements (SDEA)
with contractors.
Conduct
audits
and
trend analyses
on vigilance and quality incidents.
Track CAPA (Corrective and Preventive Actions) from audits and inspections.
System & Process Maintenance:
Support local vigilance system upkeep and participate in
internal/external audits .
Reconcile safety data and ensure consistency across reports and databases.
Maintain public reporting channels for adverse events.
Job Requirements:
At least 2 years in Pharma / Healthcare doing Quality/ISO/GMP
Minimum 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.
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