For our client, a biotech company focused on neuroscience, we are looking for a Pharmacovigilance Aggregate Report Scientist based in Amsterdam.
As a Pharmacovigilance Aggregate Report Scientist, you'll be a subject matter expert on aggregate reporting safety requirements worldwide for the PV Scientist team, Safety and the company's cross-functionally, and responsible for managing the processes for all aggregate reports (PSURs, DSURs, PADERs and local reports) and for associated pharmacovigilance activities for assigned product or group of products.
In this position, the PV Aggregate Report Scientist is part of the company's Safety Surveillance and Aggregate Reports team of
Global Safety and Regulatory Sciences (GSRS)
- 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.
- Support with process improvement; implementation and maintenance.
- Responsible for the Aggregate Reports Master Schedule and worldwide legislation overview (production, update, stakeholders review).
- Leading, coordinating and authoring responses to safety questions from regulatory authorities, in collaboration with the PV Scientist
- Contributing to initiatives for process improvement and consistency on aggregate reporting, clinical trial safety oversight, signal management and responding to ad hoc safety questions.
- Life Sciences related BSc degree (MSc, PhD, MPH, PharmD preferred)
- 5+ years of relevant Pharmacovigilance experience including aggregate safety reports writing and safety signal management.
- Experience in understanding and presenting scientific and medical date in verbal and written formats.
- Experience and willingness to work collaboratively on PV related projects.
- Familiarity with Pharmacovigilance and drug development, including knowledge of applicable clinical trial safety regulations and post-marketing safety regulations.
- Knowledge and experience with the MS Office suite and safety database systems.
T: +31 (0)639694482
When interested please react through the application process with your English resume.
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