Local Safety Officer
hace 3 semanas
Monitoring and information of CPV about local PV legislation and reporting requirements
- Preparation or request CPV for PV agreements with local parties
- Creation and periodically review of local SOPs
- Use of local PV database for case tracking
- PV interactions with local committee and LRP NIS for local non-interventional studies (NIS) and performance
- Communication to CPV about new products, partnerships, marketing actions
- Support on data protection issues
Multinational pharmaceutical company |+2 years of experience
- Bachelor´s Degree (preferably in Pharmacy)
- Master in pharmaceutical industry. Valuable PV postgraduate
- Senior profile +2 years of experience
- Experience in data entry: Intake, triage and process cases and write narratives of AE and SAE, as required
- Experience in PV archive, databases and case management
- Experience in periodic redaction/update/creation of PV SOPs
- PV legislation Knowledge (Spanish and European), GVP modules
- Valuable experience in management of PV of NIS (non-interventional studies)
- Proactive, good communication skills (verbal and written), accurate, detail orientated, teamwork skills, self-management skills, time management
Multinational pharmaceutical Company specializing in the manufacturing of vaccines and diagnostics
- Permanent contract
- Multinational team
- Social Benefits
- Hybrid position (3 days office site/ 2 days home office)
Multinational pharmaceutical Company specializing in the manufacturing of vaccines and diagnostics requires **Local Safety Officer**
Local Safety Officer
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Local Safety Officer
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Barcelona, Barcelona, España Page Personnel España A tiempo completoMonitoring and information of CPV about local PV legislation and reporting requirements Preparation or request CPV for PV agreements with local parties Creation and periodically review of local SOPs Use of local PV database for case tracking PV interactions with local committee and LRP NIS for local noninterventional studies (NIS) and performance...
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