Stufenplanbeauftragter (Stpib) / Graduated Plan

Vor 3 Tagen

Berlin, Deutschland Novasyte Vollzeit

Stufenplanbeauftragter (StPIB) / Graduated Plan Officer / EU Qualified Person for Pharmacovigilance (m/w/d)

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
- Bachelor’s Degree in a Life Science is required.
- Excellent written and verbal skills in English (min. C1) and German 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 in Germany.
- 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

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world. Learn more at

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