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SR Pharmacovigilance Scientist

SR Pharmacovigilance Scientist

(FTC 12 months - Full time - Dublin)

 

As a SR PV Scientist you will play a vital role within the Pharmacovigilance function being a central point of contact for all medical writing projects, liaising with other departments as the need arises as well as undertaking research, creation, and editing of all documents to comply with safety and clinical updates according to the internal labelling documents for all company products.

 

Responsibilities:

  • Develop a framework for setting internal and external deliverables against each medical writing project, to include project goals, objectives and measurement criteria for each project goal
  • Manage delegated tasks from QPPV, to include representation at meetings when required
  • Review, advise and approve relevant local and global guidelines, policies, internal procedures and SOPs
  • Support Risk Management Plans by serving as a coordinator for the acquisition and preparation of data for review from multiple sources
  • Collect and/or organize the data as part of Pharmacovigilance, RMP, product recalls and surveillance activities
  • Manage outsourced data collection, organization preparation with vendors as required
  • Provide support to related PV activities such as preparation of reports for surveillance support, collating reports for review of product quality data, support of health hazard evaluations, scientific presentations etc
  • Participate in preparation of analysis and writing of ad-hoc and aggregate regulatory reports and labelling support documents as well as regulatory enquiries
  • Prepare clinical and non-clinical overviews
  • Project management of contractual and financial aspects of all medical writing projects and translations and the effective utilization of resources to keep processes cost effective
  • Write clinical documents for submission to regulatory authorities, to include briefing documents, previous human experience summaries, pharmacology summaries, interim and final clinical study reports, common technical document (CTD) clinical overviews and summaries, safety update/aggregate reports, integrated summaries of safety and efficacy
  • Provide medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copy editing and content review
  • Ensure document content and style adheres to appropriate regulatory guidelines as well as complies with company SOPs and style guidelines
  • Write safety reports for signal detection / Write Annual Safety Reports
  • Ensure appropriate review/input into post-authorisation safety study protocols and study reports at local and global level
  • Oversee training and mentoring other Pharmacovigilance officers and specialists
  • Lead initiatives to develop, implement and conduct appropriate training in all aspects of Pharmacovigilance Safety activities

 

Requirements:

  • Third Level Degree in Science or a relevant discipline
  • 3-5 years' experience in the Pharmaceutical industry / Medicine Information Unit
  • Knowledge and experience of writing clinical documents for submission to regulatory authorities

 

Interested?

The next step for you:

Should this position be of interest to you please forward your CV to Renata Kormann from Next Generation Recruitment or alternatively call on the main line on +353 1 6629120.

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