For one of our clients, located in North-Brussels, we are looking for an enthusiastic Junior Pharmaceutical Affairs Officer:
- Do you have a Master degree in Pharmaceutical Sciences?
- Are you looking for a position with a diverse package of responsibilities?
- Are you fluent in English and Dutch (+ some knowledge of French)?
Then apply as soon as you can for this interesting opportunity!
As a Pharmaceutical Officer you will take part in activities such as RA, QA and PV to guarantee product compliance. You will be the central point of contact for internal and external stakeholders.
- Regulatory Affairs
- Maintenance of the Regulatory database
- Assist in the preparation of submissions for marketing authorizations, variations and renewals according to strict deadlines
- Artworks: support in the development, translation and filing of up-to-date SPC, PIL and labeling / assisting in the development and implementation of new packaging materials and leaflets
- Assist in the preparation of the necessary documents for administrative release of all products.
- Ensure adequate filing and archiving
- Quality Assurance
- Provide the necessary administrative support to audit preparation & audit reporting
- Assist in the SOP management and SOP writing
- Support in the preparation of technical agreements
- Assist in the follow-up of product complaints, including maintenance of the QA database
- Maintain training plan of employees and file & archive training materials
- Administrative support for Efpia, MDEON, samples, promotional activities, promotional materials and congress participation
- Administrative support in all PV related tasks (reconciliations, SDEA creation, PSMF update, case management and archiving, literature screening, ..)
- Providing assistance in the maintenance of local Drug Safety archive
- Translations of scientific documents/letters
- Receiving phone calls, assessing their urgency and relevance
- Composing presentations for the department on the basis of (concise) instructions
- Maintain literature database
- Coordination of medical questions arriving via phone, mail, website
- You possess a higher education: Master Pharmaceutical Sciences
- You are fluent in English and Dutch (+ a certain knowledge of French)
- You have an excellent command of MS office (Powerpoint, Word, Excel), Outlook
- You are punctual with a broad “total” company-oriented vision
- You have the ability to deal with both internal and external stakeholders, while managing different tasks at the same time
- You are autonomous, assertive and motivated
+32 15 21 11 04