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Planning, preparation, conduct, reporting and follow up of various types of GCP audits according to expected quality and timelines. Executing audits based on a comprehensive understanding of all regulatory requirements and Good Clinical Practice (GCP). Performing GCP quality assurance projects on behalf of client companies within the pharmaceutical/biotechnology industry. Assisting with business development activities.
The PV Administrative Assistant will support pharmacovigilance activities, including tracking safety messages, filing Individual Case Safety Reports, submitting reports, and preparing documents. Required skills include good IT proficiency and strong attention to detail. Training will be provided, making prior experience unnecessary.
As a PV Assistant, you'll support pharmacovigilance activities, manage safety messages, track Individual Case Safety Reports (ICSRs), and prepare periodic reports. Training will be provided, focusing on compliance and documentation accuracy.
The PV Assistant will support pharmacovigilance activities by managing safety messages, tracking Individual Case Safety Reports (ICSRs), and maintaining archives. Training will be provided, and the role requires strong organizational and communication skills.
The QA Associate will assist the QA team in managing and conducting internal and external audits in accordance with PrimeVigilance procedures, support audit scheduling and tracking, and maintain documentation related to audits and CAPA activities.
The Benefit/Risk Associate will participate in signal detection activities, review line listings, draft signal detection reports, maintain relevant tracking tools, and collaborate with other departments to ensure compliance with procedures and regulatory requirements.
The Accounting Assistant will provide support to the Finance Department by processing invoices, communicating with vendors regarding payments, ensuring approval, archiving documentation, and collaborating with team members. This role requires attention to detail and effective communication skills.
The PV Associate/Literature is responsible for literature monitoring, assisting with literature searches and screenings, and ensuring compliance with safety services for pharmaceutical companies. The role involves data tracking, peer review quality control, and preparing for regulatory inspections.
The PV Associate will support pharmacovigilance activities, processing Individual Case Safety Reports, and reconciling reports while working under supervision. This entry-level position is designed for recent graduates with life science backgrounds looking to start their careers in drug safety.
The role requires monitoring local scientific literature for adverse event reports, refining search strategies, providing translation or revisions of documents, and maintaining files according to PrimeVigilance procedures. This position is suited for a freelancer with a life sciences background and fluency in both German and English.
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