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Life Sciences Aggregate Reports Expert

vor 3 Wochen


Baar, Zug, Schweiz K-Recruiting Life Sciences Vollzeit

At K-Recruiting Life Sciences, we unite the people who make our world healthier by placing top experts with life sciences companies worldwide. We are looking for a talented individual to join our team as an Aggregate Reports Expert. As a key member of our Safety Surveillance and Aggregate (SSA) Reports team, you will be responsible for managing the processes for all aggregate reports.

The ideal candidate will have a strong background in pharmacovigilance, with experience in writing and managing aggregate safety reports. You will serve as a subject matter expert on relevant safety requirements and company policies/procedures related to pharmacovigilance activities, as well as aggregate reports knowledge.

Your primary responsibilities will include:

  • Project management and authoring of aggregate safety reports such as PSURs, DSURs, PADERs, local reports in collaboration with the PV scientist Lead.
  • Serving as a subject matter expert on relevant safety requirements, company policies/procedures related to pharmacovigilance activities, as well as aggregate reports knowledge.
  • Supporting process improvement; implementing and maintaining processes.

In addition, you will be responsible for the Aggregate Reports Master Schedule and worldwide legislation overview. You will work closely with the PV Scientist lead to coordinate and author responses to safety questions from regulatory authorities.