- Planning and coordination of regulatory procedures. - Assessing the quality of the applications.- Supporting Medicines Evaluation Board in making decisions. - Contributing during board meetings, internal and external consultations and hearings.- Maintaing contact with pharmaceutical companies and fellow assessment authorities in the EU.

Pharmacovigilance- Local Qualified Person for Pharmacovigilance (local-QPPV)- Review literature for pharmacovigilance purposes- Reconciliation of safety information with other departments and third parties- Management of pharmacovigilance agreements- Pharmacovigilance training of personnel- Quality control of local pharmacovigilance system including development and maintenance of Standard Operating Procedures (SOPs)Regulatory Affairs- Responsible for planning and managing all regulatory activity associated within the BeNeLux- Liaise with relevant internal departments (for example medical, marketing, market access) and external contacts to ensure regulatory requirements for these submissions are met- Communicate with regulatory authorities in order to expedite approval for submissions- Responsible for approval and implementation of direct healthcare communications (DHCPs) and additional risk minimisation measures (aRMM) in the BeNeLux

Pharmacovigilance:- Responsible for collection, processing and follow-up of adverse events (AEs) and serious adverse events (SAEs).- Review literature for pharmacovigilance purposes- Reconciliation of safety information with other departments and third parties- Pharmacovigilance training of personnellRegulatory Affairs- Ensure compliance of local productinformation with company core datasheets and local guidelines- Initiate change of packaging of products- Communicate with regulatory authorities in order to expedite approval for submissions- Liaise with relevant internal departments (for example medical, marketing, market access) and external contacts to ensure regulatory requirements for these submissions are metMedical - Medical representative in brandteam responsible for respiratory products.- Setting up materials for patients (for example patient brochures) and co-develop/review marketing materials- Medical training of employees (product specific and general pharmaceutical knowlegde)- Anwering medical questions from patients and healthcare professionals

Validation and implementation of webbased application for prescribing, preparing and administering oncology drugs- Liaise with relevant internal stakeholders (for example oncologists, hospital pharmacists, oncology nurses, IT staff) and external contacts- describe the user requirement specifications for 'Mediware' (closed-loop application for prescribing, preparing and administering oncology drugs)- setting up validation and projectplan for implementation of Mediware- performing a risk-analysis in order to identify possible GMP and safety risks - validation of Mediware and implemention in hospital pharmacy