Our client is a consultancy in the food and pharmaceutical industry. They participate in very attractive projects for experienced engineers in the pharmaceutical industry. They offer challenging, varied projects with ample opportunities for personal contributions and development.
Currently our client is looking for a Drug Safety Officer. In this role you are acting as a contact person for any safety issues of pharmaceutical products.
- Managing of product safety information;
- Ensuring that safety information is collected, translated and forwarded to pharmacovigilance headquarters, in compliance with quality guidelines;
- Ensuring that inspections and audits are ready and support an inspection or audit if needed;
- Ensuring the filing, storage and archiving of pharmacovogillance documentation in accordance with regulations;
- Managing and coordinating all pharmacovigilance activities in alignment with regulatory requirements;
- Implementating relevant updates to pharmacovigilance regulations;
- Maintenaning the pharmacovigilance system;
- Responsible for the Quality Management System (QMS), including Quality Assurance (QA) and Quality Control (QC) activities;
- Participating in activities concerning Risk Management Plans and Risk Minimization Measures;
- Ensuring implementation and documentation of product safety awareness through giving trainings
- Minimal two years of work experience within druf safety;
- Good communicator and teamplayer;
- Prepared to be available by phone 24/7;
- Good communication skills in Dutch and English