Personne de reference en matière de pharmacovigilance

Personne de reference en matière de pharmacovigilance

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