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
Quality Assurance Officer
Key responsibilities
- Support the Quality Assurance (QA) department
- Prepare the administrative release of finished products (medicinal products/medical devices)
- Follow-up on the implementation of new artwork
- Evaluate the destination of returned products
- Handle product complaints and deviations
- Assist in activities related to final product release by the QP (review batch documentation)
- Write and implement standard operating procedures according to customer specifications
- Ensure compliance with all applicable GDP/GMP regulations
- Prepare and provide adequate training regarding QA procedures to staff and contractors
- Participate in self-inspections and audits
- Prepare quality variation dossiers in cooperation with the Regulatory Affairs department
- Manage the QA documentation