Medical Writer - Safety
A pharmaceutical business that focuses on the development and manufacturing of anaemia are looking for a medical writer based in Glattbrugg/Zurich.
- Production of high quality periodic and cumulative aggregate safety reports for the different products in compliance with ICH, FDA and EMA guidelines
- Participation in signal detection and assessment
- Quality control of reports written internally and from external support
- Timely handling of aggregate safety reports to Regulatory Affairs (RA) for compliant submissions
- Providing support for compliance of benefit/risk surveillance to Clinical, Medical, Regulatory and Safety teams (CMRSTs),
- Effective and timely implementation of CAPA as result of Audits and Inspections
- Maintenance of updated SOPs as per new regulations and change in processes
- Developing further support activities of the Medical and Clinical Safety Centre of Excellence
Skills and Requirements
- University degree in pharmacology, medical or other life science field.
- Minimum of 5 years of working experience in post marketing surveillance / drug safety, medical writing of ASRs and case classification.
- Good knowledge of ICH, FDA and EMA guidelines
- Fluency in English
- Excellent user of Microsoft Office (Word, Excel, PowerPoint, Outlook)
- Experience in PV Quality Management, procedural documents, compliance metrics, PV training, audits and inspections, CAPA management
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical and medical device companies.