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.

Job Responsibilities

• 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

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical and medical device companies.

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