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  Medical Affairs Manager, UK & Benelux cluster lead F/M  M/F (28191)

 

Medical Affairs Manager, UK & Benelux cluster lead F/M

 

Location: Belgium

 

Permanent contract to be filled as soon as possible

 

Guerbet is seeking an accomplished Medical Affairs Manager, based in Belgium to lead the development of the medical affairs strategy and programs within the UK/Benelux cluster.

This role will be responsible to ensure accurate, robust and appropriate medical/scientific exchange with internal and external stakeholders.

 

OUR OFFER

 

You will be the signatory medical doctor or pharmacist qualified person for the cluster. A registration as local Qualified Person in Pharmacovigilance (QPPV) for Benelux is desirable.

The Medical Affairs Manager Cluster lead will bring strong leadership qualities, high level of cross-functional collaboration and the ability to influence across all levels of the organisation. Passion for the patient community and commitment to patient advocacy are paramount for this position:

 

I- Common missions for this position

 

 Pharmacovigilance (PV)

 

• Implements locally the PV policy according to the Group PV policy, strategy and objectives as defined by the Head of the Corporate PV department.
• Is in charge of the local scientific and regulatory intelligence in PV. Provides his/her expertise and support to analyze the impact of new regulations and to apply them. Is responsible for the local compliance with the applicable quality referential and their evolution in his country.
• Evaluates and follows the risks associated with the clinical use of pre- and post-marketing pharmaceutical products of the Group in his/her country.
• Proposes measures intended to minimize these risks, to promote the best usage of the products and to guarantee the patients’ safety in his/her country.
• Identifies the critical information on his/her perimeter and is involved in its collection, analysis, utilization, circulation, protection, and archiving.
• Is responsible for the update of the quality documentation related to PV. Provides his/her colleagues with these documents and explains them.
• Develops the competencies, the performances, and the implication of the local team in PV.
• Defines and coordinates the needs for training and the resources involved in PV in his subsidiary.
• Is the reference person in PV working at the interface with the authorities, as well as customers and suppliers.
• Is the contact person dealing with the authorities and healthcare professionals on his perimeter.
• Prepares and follows the course of the inspections and audits. Is involved in the local implementation of the preventive and corrective actions.
• Follows the recommendations and guidelines about health, safety, and environment.

 

  Regulatory affairs (RA) subcontracted.

 

• Is the contact person dealing with the authorities for RA
• Checks the legal and regulatory compliance as well as the scientific content of the documentation sent by Corporate RA department. Submits variations, renewals, or new marketing authorization applications to his competent authority. Attaches any relevant documentation according to the local requirements.
• Is in charge of the follow-up of the pending approvals. Answers some questions and provides additional documentation when requested by the agency. Informs the pharmacists from the Corporate RA department about the approval status of the dossiers.
• Is in charge of the local regulatory intelligence. Informs the Corporate RA department about new regulation.
• Proposes some regulatory strategies based on his/her experience and knowledge of the local regulatory and quality laws.
• Revises and validate the texts of the packaging materials of the products.

 

  Pharmaceutical affairs

• Manages product quality complaints.

 

 Quality assurance

 

• Checks the compliance with the good practices (GMP, GDP, GCP).
• Implements locally and communicates about the quality assurance system and its evolution.
• Writes, revises, gives out and maintains the locally applicable quality assurance documentation.
• Organizes audits and implements the corrective actions in the subsidiary.

 

 Scientific information

 

• Revises and approves promotional materials according to the law in force.
• Revises and validates the scientific documentation used for the education of the sales force (e-learning…).
• Performs the scientific training of the sales representatives about products and imaging techn