Specialist, Patient Safety
24 months contract
Description
The group is responsible for pharmacovigilance and pharmaco-epidemiology deliverables including single case and aggregate safety monitoring, safety reporting, contribution to benefit-risk assessment, risk management planning and strategy, and execution of certain post-marketing commitments and ensuring compliance with global regulatory requirements.
Position Responsibilities
- Risk management plans
- Provision of safety information
- Implementation of PV Audit and Inspection Readiness
- Planning, processing and reporting of Aggregate Reports to HA and EC (as required)
- Maintenance of PV Awareness and Training
- Implementation of Pharmacovigilance Agreements
- As applicable, collection, follow-up and forwarding of spontaneous, literature, solicited, post- marketing AE cases
- Submission of single cases to local Health Agencies (HA) and Ethics Committees (as required)
- Local Market Safety Data Quality
Requirements
- Bachelors degree (preferably life science) or nursing qualification.
- Some experience of working in a medical environment or a reasoned desire to gain experience in PV.
Interested applicants may apply.
Bexlyn Chiu R1985241
EA Licence: 08C5248
