English-writer

il y a 1 semaine


Paris, France ProductLife Group Temps plein

ProductLife Group is looking for a Medical Writer and LRPPV France to join our dynamic team to contribute to the activities performed in the Hub:
Acting as LRPPV in France and as single point of contact to French health authorities
Answers to questions from authorities (national, European surveys, ad hoc answers) requiring medical analysis
Represents medical writing as part of a global, cross[1]functional team and work independently to successfully drive the production and development of each deliverable document following the client business process.
Understands and interprets clinical and scientific reports to allow the accurate capture of safety and efficacy data. Interprets and presents scientific data, analyses and appraise clinical, biomedical and scientific reports in a systematic, accurate, fair and balanced way.
Analyses clinical evidence of all kinds (public, proprietary, published, or unpublished, etc.) from all sources (journals, internal documents, regulatory submissions, etc.) Writes ad hoc reports based on these literature searches.
Identify suspected spontaneous adverse drug reaction reports from the information given by customers during enquiry handling and ensure they are accurately reported to the appropriate Pharmacovigilance LOB in line with legal and company requirements
Provides timely, accurate, appropriate and clear verbal and written information in response to enquiries about PLG customers’ products or therapy areas in order to facilitate the appropriate, effective, safe and continued use of company product

Supports other Medical Writer and the Activity manager in reviews metrics to assess accuracy, quality and regulatory compliance of MI VI outputs.
Participates in training as required for ProductLife Group.
Pharmacist or medical degree
Use of Microsoft Office tools
Excellent communication skills in French and in English for business continuity


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