Safety Writing Scientist

Proclinical has partnered with a top 50 Biotech is looking to strengthen their Patient Safety and Medical Management Group. This organisation are looking for a talented individual to fill the position of Safety Writing Scientist. This role can be based in Europe, the UK or the US. This is an opportunity to be a part of a mentoring and developing schemes and work on products that will make a real impact on patient lives

Job Responsibilites

• Manage the preparation, provide scientific analysis and writing acumen to effectively articulate for benefit-risk assessments, safety risk management strategies, safety signal assessments, regulatory submissions and aggregate reports
• Provide mentorship and oversight for the vendor preparing some of the deliverables
• Actively participate in team/product meetings to give input based on scientific expertise and awareness of business implications
• Project manage and champion continuous improvement initiatives as well as assure quality and consistency across Patient Safety deliverables, including compliance with regulatory requirements and compliant with agreed and defined timelines

Skills and Requirements

• Bachelor's Science degree or the equivalent
• Extensive experience in pharmacovigilance and medical writing, including working with vendors
• A good understanding of applicable regulations in pharmacovigilance
• The ability to gather data from relevant sources using appropriate methods and logic, and interpret, analyze, draw meaningful conclusions and clearly present scientific and technical data in verbal and written format
• The ability to project manage deliverables in a matrix environment with competing priorities, as well as demonstrated experience working in a matrix managed environment

To Apply

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

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