Local Pharmacovigilance Responsible Person
Company: IQVIA
Location: Courbevoie
Start Date: 19 Mar 2025
Closing Date: 18 Apr 2025
Job Type: Full-time
Main Responsibilities:
24/7 Availability: Serve as the primary contact for the local Competent Authority to receive calls as needed.
Inspection Contact Point: Act as the key contact for pharmacovigilance inspections.
Regulatory Requests: Respond to requests from Competent Authorities regarding benefit-risk evaluations, sales, prescriptions, or post-authorization safety studies.
Notification Management: Ensure the Competent Authority is notified of contact details upon contract initiation.
Regulatory Compliance: Stay updated on local regulatory requirements and ensure that necessary safety measures and risk management plans are implemented.
Project Oversight:
Establish and maintain a thorough understanding of project budgets and scope of work (SOW).
Set up and manage project materials, including files, forms, templates, databases, and workflows.
Provide regular reports to project managers and participate in project review meetings.
Communicate and document project issues to the team and management promptly.
Regulatory Reporting: Provide regular monthly updates to the EU QPPV/designee and complete required regulatory reports.
Required Knowledge, Skills, and Abilities:
Educational Qualification: Doctor of Pharmacy (PharmD) or Medical Doctor (MD) degree is mandatory.
Language Skills: Excellent written and verbal communication skills in English (C1 minimum) and French (C2/native level).
Regulatory Knowledge:
In-depth understanding of global, regional, and local regulatory requirements and ICH guidelines.
Strong knowledge of the pharmacovigilance legal framework in the EU and France.
SOP Knowledge: Familiarity with relevant Standard Operating Procedures (SOPs).
Inspection Experience: Ability to directly interact with Competent Authorities and respond effectively during statutory inspections.
Analytical & Problem-Solving: Excellent analytical skills for interpreting safety reports and literature during inspections.
Safety Profile Oversight: Maintain a comprehensive understanding of the product’s safety profile and factors influencing benefit/risk balance.
Compliance Awareness: Demonstrate a strong understanding of compliance and quality management systems.
About IQVIA:
IQVIA is a global leader in providing clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. By creating intelligent connections, IQVIA accelerates the development and commercialization of innovative medical treatments to improve patient outcomes and global health.
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