Safety Officer
Key responsibilities
- Comply with vigilance best practices and provide input to contribute to the evolution of the departments activity
- Stay ahead of changes in regulatory requirements in relation to safety (pharmacovigilance and materiovigilance)
- Ensure that all safety information is efficiently handled and submitted within the legally defined timelines according to standard operating procedures and working instructions
- 24/7-call handling and administration
- Case processing
- Literature screening
- Assist, review or draft aggregate reports
- Participate in self-inspections and audits
- Develop and deliver training regarding vigilance procedures to staff and contractors
- Interact with the Regulatory Affairs & Quality Assurance department
Regulatory Affairs Officer
Key responsibilities
- Assist and support the Regulatory Affairs department
- Prepare, verify and adapt product information
- Provide scientific support for marketing authorisation dossiers, notifications and technical dossiers
- Submit registration and notification dossiers to health authorities
- Manage the life cycle of the client portfolios (variations, renewals…)
- Proofread leaflets and labeling
- Support evaluation of promotional activities
- Maintain records and files