Medical Writer - Safety job in Zürich, Switzerland

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First Name*

Last Name*

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Phone Number*

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Are you an employer or a jobseeker?*

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First Name*

Last Name*

Email*

Phone Number*

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Are you an employer or a jobseeker?*

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First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

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Job type: Permanent

Discipline: Medical Liaison

Location: Switzerland

This vacancy has now expired

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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