N120 Head of Medical (Biologics)

Descripción del trabajo

Última actualización: hace 19 horas

MAIN RESPONSIBILITIES

• Availability on a 24 / 7 basis to receive calls from the local Competent Authority as required.
• Act as the contact point for Pharmacovigilance inspections.
• Respond to requests from Competent Authorities to evaluate the benefits and risks of a medicinal product to include information regarding sales or prescriptions or post-authorization of safety studies of medicinal products.
• Verifies that his / her name and contact details have been notified to the Competent Authority upon contract commencement.
• Remain up to date and aware of any changes in local regulatory requirements; verifies the necessary mechanisms and regulatory measures adopted for safety reasons and the risk management plans are carried out.
• Establish and maintain a thorough understanding of each project’s budget and scope of work (SOW); set up and maintain project materials such as project files, forms, templates, databases and workflow.
• Work in a collaborative team environment with project team members both remotely and onsite.
• Provide regular reports to project manager on project metrics, SOW changes, customer requests or concerns; participate in project review meetings with management, communicate and document project issues to project team members and department management in a timely manner.
• Communicate regular monthly updates to the EU QPPV / designee & complete regulatory reports as required.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

• Doctor of Pharmacy or Medical Doctor Degree is a must.
• Excellent written and verbal skills in English (min. C1) and French language (min. C2 / native).
• In-depth knowledge of applicable global, regional and local regulatory requirements; and International Conference on Harmonization (ICH) guidelines.
• In-depth knowledge of the pharmacovigilance legal framework in the EU and France.
• Very good knowledge of relevant Standard Operating Procedures (SOPs).
• Deal directly with the Competent Authority and undergo questioning by regulatory authority inspectors during statutory inspections.
• Excellent analytical and problem-solving approach when interpreting safety reports, literature and undergoing inspections.
• Maintain an overview of the safety profile of the product and factors that may affect the benefit / risk balance of a product.
• Demonstrate an understanding of compliance and of quality management systems.