Play a key role in reviewing and improving pharmacovigilance documentation within a leading biotech company.

Sr. PV Scientist, Quality Document

Job 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 extension

Workload: 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.