Lab Technician Scientist in a QC Bioassay Lab

vor 1 Woche

Luzern, Schweiz Gi Group SA Vollzeit

The Aggregate Reports PV Scientist as part of a team is responsible for managing the processes for all aggregate reports (PSURs, DSURs, PADERs and local reports) acting as the SME for these reports. The responsibilities will be around the following task areas :

  • Project management and authoring of aggregate safety reports such as PSURs, DSURs, PADERs, local reports in collaboration with the PV scientist Lead
  • Acting as a SME on relevant safety requirements, company policies / procedures related to pharmacovigilance activities, as well as aggregate reports knowledge
  • Supporting with process improvement; implements and maintains processes
  • Ideally responsible for the Aggregate Reports Master Schedule and worldwide legislation overview (production, update, stakeholders review)
  • In collaboration with PV Scientist lead coordinating and authoring responses to safety questions from regulatory authorities
  • Contributing to initiatives for process improvement and consistency regarding aggregate reporting, clinical trial safety oversight, signal management and responding to ad hoc safety questions

In order to be considered for the role, the selected candidate must have :

  • Master degree or degree in Life Sciences or related field
  • 8+ years work experience in PV incl. with strong focus on authoring aggregate reports (min.2 years)
  • Strong pharmacovigilance and drug development foundation, including knowledge of applicable clinical trial safety regulations and post-marketing safety regulations
  • Ability to collaborate in a team, cross functional (including Safety, Clinical Development, Medical Affairs, Clinical Operations, and Regulatory), as well as with external colleagues
  • Represents and speaks to processes in cross-Safety and cross-functional forums
  • Familiarity with Pharmacovigilance and drug development, including knowledge of applicable clinical trial safety regulations and post-marketing safety regulations. Includes familiarity with case processing, expedited reporting rules, and safety database concepts
  • Knowledge of common data processing software as well as common safety database systems
  • Strong communication skills in English and organisational skills

The selected candidate will be part of a dynamic team and actively contribute to the discovery, development and delivery of innovative therapies to improve the lives of patients.

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