Medical Affairs Manager
That's XPE. For one of our clients we are looking for: Medical Affairs Manager Organisation description:
Our client, an innovative pharmaceutical group dedicated to medical imaging worldwide and pioneer in contrast media, is hiring a motivated, trilingual (NL-FR-EN) Medical Affairs Manager with experience in pharmacovigilance and clinical trials, this is a full time permanent contract.
You are a member of the Benelux Medical Affairs Department and you're main focus will be on Pharmacovigilance, Scientific information & Medical advising and clinical trial coordination.Job description:
You evaluate and minimize risks associated with clinical use of the products and you promote the best usage of these products to ensure patient safety.
Manage ICSRs and search in local literature for potential product-related PV cases are daily business.
In addition, you manage PV audits & inspections and implement preventive and corrective actions.
Developing the local PV team, their competencies & performances and coordinating the local resources are part of your responsibilities.
The sales force needs to be trained on pharmacovigilance and the local teams need a clear explanation when an update of the quality documentation, related to PV, has occurred.
Furthermore, you are the PV contact to the Competent Authorities for requests for periodic reports, safety issues, submission of the risk management plan and implementation of related actions in the territories.
Scientific Information and Medical Advising
Scientific, medical or radiological enquiries about the products need to be answered.
Another responsibility of yours is the review & approval of promotional materials, translations of the SmPCs & PILs and sign conformity certificates.
Next to pharmacovigilance you are also the scientific trainer of the sales force and you support the local marketing department.
Your tasks also include the validation of scientific documentation used for sales training (e.g. e-learning modules).
On top, you give scientific lectures about the products and their use in medical imaging, during scientific events or in hospitals.
You are member of the Medical Information Network at the Group level and you have daily interactions with experts and key opinion leaders in the field (incl. organization of advisory board meetings).
You identify potential clinical study sites / investigators in the Benelux and manage contract signatures with the involved principal investigators and hospital heads.
Next, you follow-up on the clinical study authorization application and you answer to questions of the Competent Authority or ethical committee.
You support the management of queries from case report form to global non-interventional study.
The design and management of local non-interventional studies fall within your responsibilities as the management of the proposals of investigator-initiated studies in territories (including collection of protocols, give scientific recommendations and follow-up on the studies).Profile:
You are a pharmacist or medical doctor with experience in contrast media, clinical trials and management of local pharmacovigilance activities.
Dutch, French, and English hold no secrets from you and you can effectively and fluently communicate in all 3 languages.Offer:
You are offered a permanent, full time contract on the client's payroll and a competitive salary including an extra-legal package.
Last but not least, you gain experience in an innovative, international, challenging and rewarding working environment.
XPE Personnel Services NV/SA: Flanders: VG15/BU, Brussels: B-AA5.031, Wallonia: W.RS.002/W.INT.002 XPE Group NV/SA : Flanders: VG1834/B, Brussels: B-AA11.007, Wallonia: W.RS.713