Local Pharmacovigilance Responsible Person
Local Pharmacovigilance Responsible Person
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Job Description
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 postauthorization 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 projects 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).
Indepth knowledge of applicable global regional and local regulatory requirements; and International Conference on Harmonization (ICH) guidelines.
Indepth 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 problemsolving 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.
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Employment Type
Full-Time
