Local Pharmacovigilance Responsible Person
Company: IQVIA
Location: Courbevoie, France
Start Date: 19 Mar 2025
Closing Date: 18 Apr 2025
Job Type: Full-time
Main Responsibilities:
24/7 Availability: Be available to receive calls from the local Competent Authority as required.
Inspection Contact Point: Act as the contact for Pharmacovigilance inspections.
Competent Authority Requests: Respond to requests from Competent Authorities to evaluate the benefits and risks of a medicinal product, including sales, prescriptions, and post-authorization safety studies.
Regulatory Compliance: Ensure that personal contact information is updated and notified to the Competent Authority upon contract commencement.
Stay Updated on Regulations: Monitor and implement any changes in local regulatory requirements, ensuring that safety measures and risk management plans are followed.
Project Oversight:
Establish and maintain an understanding of project budgets and scope of work (SOW).
Set up and maintain project files, templates, databases, and workflows.
Team Collaboration: Work collaboratively with project team members remotely and onsite.
Reporting & Documentation:
Provide regular reports to project managers regarding project metrics, SOW changes, and customer concerns.
Participate in project review meetings and document project issues for relevant stakeholders.
Regulatory Communication: Provide monthly updates to the EU QPPV/designee and complete required regulatory reports.
Required Knowledge, Skills, and Abilities:
Degree Requirement: Doctor of Pharmacy or Medical Doctor Degree.
Language Proficiency:
Excellent written and verbal skills in English (min. C1).
Native or C2 level proficiency in French.
Regulatory Knowledge:
In-depth understanding of global, regional, and local regulatory requirements, including International Conference on Harmonization (ICH) guidelines.
Knowledge of the pharmacovigilance legal framework in the EU and France.
SOP Proficiency: Strong understanding of relevant Standard Operating Procedures (SOPs).
Regulatory Authority Interaction: Ability to engage with the Competent Authority and undergo questioning by regulatory inspectors during statutory inspections.
Analytical & Problem-Solving Skills: Proficiency in interpreting safety reports, literature, and handling inspections.
Safety Profile Management: Maintain an overview of the safety profile and factors affecting the benefit/risk balance of the product.
Compliance & Quality Management: Demonstrate a strong understanding of compliance and quality management systems.
About IQVIA:
IQVIA is a global leader in clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries. IQVIA creates intelligent connections to accelerate the development and commercialization of innovative medical treatments, improving patient outcomes and population health worldwide.
For more information, visit https://jobs.iqvia.com
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