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Medical Affairs Manager Benelux - Based in Brussels - Belgium  

Guerbet (company)

Posted on : 01 May 2017

Project Description

Job reference REC170109
Type of contract Permanent
Duration Permanent
Location Belgium
Sector Recherche et Innovation
Direction Recherche and Innovation

Primary mission

I- Common missions for this position

(territories = Belgium + Luxembourg + the Netherlands)

A – Pharmacovigilance (PV).

The responsibilities of the RPPV in territories are :

- Implementation of the Group PV policy, strategy and objectives.

- Compliance with the recommendations and guidelines about health, safety and environment.

- Compliance with the applicable quality referentials.

- Scientific and regulatory intelligence on PV.

- Evaluation and follow-up of the risks associated with the clinical use of the products. Implementation of measures to minimize these risks, promote the best usage of the products and ensure patient safety.

- Collection of ICSRs, transfer to the Corporate PV department in agreed timeframes, follow-up in territories, and archiving.

- Regular search for potential product-related PV cases in the local literature. Follow-up addressed to the authors of the published articles.

- Definition and coordination of the local resources involved in PV.

- Development of local team competencies and performances in PV.

- Sales force training about new PV regulations applicable to the products.

- Update of the quality documentation related to PV. Transfer of the relevant documents with explanations to the local teams.

- Preparation and follow-up of PV audits and inspections. Implementation of the preventive and corrective actions.

- PV contact person for Competent Authorities, HCPs and suppliers.

- Information of the Corporate PV department about Competent Authorities’ requests for periodic reports. Filing and archiving of these periodic reports.

- Notification to the Corporate PV department of any PV request or safety issue received from the Competent Authorities.

- Involved in the preparation of PV response documents to the Competent Authorities. Submission of such documents or changes in benefit-risk balance to the Competent Authorities.

- Submission of the risk management plan to the Competent Authorities. Implementation of related actions in territories.

- Management of the process of communication with HCPs in compliance with the deontological code.

B – Regulatory affairs

- No responsibility.

C – Pharmaceutical affairs

- No responsibility.

D - Quality assurance

- No responsibility.

E - Scientific information

- Revision and approval of the translations of the SmPCs and PILs. Signature of the certificates of conformity.

- Revision and approval of promotional materials according to the applicable laws and the deontological codes in territories.

- Answer to scientific, medical or radiological enquiries about the products.

- Participation to the Medical Information Network at the Group level.

- Scientific lectures about the products and their use in medical imaging, during scientific events or in hospitals on demand.

- Communication with experts and key opinion leaders.

F - Medical advisoring

- Revision and validation of the scientific documentation used for sales force training (e.g. e-learning modules).

- Scientific training of the sales force about products and imaging techniques.

- Scientific support to the local marketing and sales force.

- Organization of and attendance to advisory board meetings.

G - Clinical studies

- Identification of potential sites / investigators for clinical studies in territories. Information transerred to the Corporate Clinical Development department.

- Check of the compliance of the clinical study documentation with the local SmPCs and PILs.

- Follow-up of the clinical study authorization application. Answer to Competent Authority or ethical committee questions after discussion with the local RA Officer and the Clinical Project Manager.

- Management of the contract signatures with the principal investigators and the heads of the hospitals involved in the study.

- Help for the management of the queeries from the case report forms of patients participating to global non-interventional studies.

- Design and management of local non-interventional studies.

- Management of the proposals of investigator-initiated studies in territories : collection of the study protocol, scientific recommendation to the Corporate Medical Affairs Manager, management of the contract signature after approval, and study follow-up.

II- Specific missions for this position

(territories = Belgium + Luxembourg + the Netherlands)

- Registered as local Responsible Person in Pharmacovigilance (L-RPPV).

- Hierarchical Manager of an Assistant : Mrs. Nadine Delavigne.

- Functional Manager of the PV Contact Person in the Netherlands :

Mr. Ergün Serce

Candidate profile

- Pharmacist or medical doctor with good competences in contrast media, with sufficient qualifications and experience to locally manage PV activities, and with a good knowledge about clinical studies.

- Fluent in French and Dutch. Good level in English.