Manage regulatory affairs and function as direct contact person with FAMHP.
Responsible pharmacist and quality manager for the distribution of medicines and medical devices in Belgium and GD Luxembourg.
The responsibilities include the following:
- ensuring that a quality management system is implemented and maintained;
- committing to the management of licensed activities, as well as to the accuracy and quality of documentation;
- ensuring that initial and in-service training programs are implemented and maintained;
- coordinating and promptly executing drug recalls
- ensuring that relevant customer complaints are handled effectively;
- ensuring that suppliers and customers are recognized;
- approving any outsourced activities that may affect GDP;
- ensuring that self-inspections are performed at appropriate and regular intervals according to a pre-established schedule and that necessary corrective actions are taken;
- accurate registration of delegated tasks;
- deciding on the final destination of returned, rejected, recalled or counterfeit products;
- giving approval for products to be added back to saleable inventory;
- ensuring the compliance with any additional requirements from national legislation that apply to certain products.
Timely execution of the recall process at the health services, and timely notification to Global QA of the advice obtained from the health services
Local Pharmacovigilance Officer and Contact Point Materiovigilance: collecting local reports of ADEs / Incidents occurred on Belgian and Luxembourg territory (commercial sale or clinical trials).
Answering medical questions
Non-exhaustive list of tasks and responsibilities that can be expanded following the evolution of legislation and requirements in the field of RP / QA / RA and Pharmacovigilance / Publicity in Belgium and GD Luxembourg.