QA-PV Associate 100%
SFL Group and its dynamic cross-functional team provide premium consulting support to companies in the healthcare and life sciences fields. Our clients range from established top 10 pharma and medtech companies to newly founded start-ups.
In our Basel office, we have an open position for a Quality Assurance – Pharmacovigilance Associate (planned start as of 1 October 2020).
- Support the Quality Assurance and Pharmacovigilance team on a project by project basis
- Draft, finalize and compile Standard Operating Procedures (SOPs)
- Contribute to the maintenance of SFL’s own Quality Management and Establishment License as well as clients’ Quality Management Systems
- Track change controls, corrective and preventive action plans and quality metrics information
- Aggregate safety data, and write and compile safety reports
- Review client documents and correspondence in the context of rare diseases and genetic disorders
- Ensure that documents and reports are well-organized with a proper flow of information and accurate in content and language
- Work according to pre-defined objectives and timelines in compliance with applicable regulations and guidelines
- Provide ad-hoc support to other functions at SFL, as necessary
Qualifications and requirements
- PhD in life sciences or related field
- Relevant first experience in the preparation and management of regulated documents and compliance with regulated processes (e.g. SOP, GxP, ICH)
- Strong interest in Quality- and PV-related regulation of drugs and devices
- Experience working with data bases
- Structured and accurate working style, attention to detail
- Open-minded personality, interested to learn in an international environment
- Excellent in English orally and written; additional languages (German and French) welcome
- Strong interest in pharmaceutical and medtech industry
We provide globally active pharma and medtech companies with customized services and solutions in Regulatory Affairs, Quality Assurance/Pharmacovigilance/Supply Chain, Medical Affairs, Public Affairs & Regulatory Intelligence, Market Access & Reimbursement, and Legal & Compliance.
Expertise, innovation, development, respect and ethical behavior are our values and corner stones of our company culture and key to our success and excellent reputation.
Please send your application with CV, motivation letter and references until 20 September 2020 (midnight CEST) via email to firstname.lastname@example.org (no paper applications or phone calls).