Sr. Pv Scientist, Quality Document

Play a key role in reviewing and improving pharmacovigilance documentation within a leading biotech company.Sr. PV Scientist, Quality DocumentJob description:Our client, a global biotechnology company, is looking for a Senior Pharmacovigilance Scientist, Quality Document Manager to support high-quality pharmacovigilance documentation and quality processes within the Safety Surveillance & Aggregate Reports team. This is an excellent opportunity for someone with strong medical writing and pharmacovigilance experience who enjoys working in a collaborative, quality-focused environment. About the customer:Role: Senior Pharmacovigilance Scientist, Quality Document Manager Location: Baar, Switzerland Start: ASAP Duration: 12 months with possible extensionWorkload: 100% Requirements:Perform quality control (QC) reviews of pharmacovigilance and aggregate safety documents to ensure accuracy, consistency and compliance with internal quality standards. Verify source data against database outputs and supporting documentation, reviewing scientific, technical and editorial content for accuracy, grammar and consistency. Provide detailed feedback to document authors, support the resolution of findings and contribute to high-quality document delivery. Review vendor-authored documents as part of quality oversight activities and support vendor management processes. Assist with the development and maintenance of templates, QC checklists, training materials and job aids. Support quality trend reporting, process improvement initiatives and cross-functional projects within the Safety Surveillance & Aggregate Reports team. Contribute to general administrative activities, including SharePoint maintenance, spreadsheet management and communication of quality metrics and results. Provide support to additional SSA activities such as aggregate report processes, literature activities and vendor coordination when required. Competences:Bachelor's degree in Life Sciences, Natural Sciences, Healthcare or a related scientific discipline. Minimum 2–3 years of experience in pharmacovigilance, medical writing, scientific editing or document quality review within the pharmaceutical or biotechnology industry. Strong understanding of pharmacovigilance, clinical trial safety, post-marketing safety regulations, case processing, expedited reporting and safety database concepts. Excellent written English with strong scientific writing, editing and document review skills;
comfortable working with medical terminology. Experience reviewing scientific documents with exceptional attention to detail and the ability to identify inconsistencies and quality issues. Strong organisational skills with the ability to manage multiple priorities independently. Proficiency in Microsoft Office (Word, Excel and PowerPoint);
experience with document management systems and SharePoint is an advantage. Collaborative team player with excellent communication skills and the ability to work effectively across cross-functional teams.
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