Job Overview
The Aggregate Reports PV Scientist is a key member of the team responsible for managing aggregate reports (PSURs, DSURs, PADERs, and local reports). As a Subject Matter Expert (SME), they will oversee processes related to these reports.
Key Responsibilities
* Project management and authoring of aggregate safety reports in collaboration with the PV scientist Lead.
* Acting as an SME on relevant safety requirements, company policies/procedures, and aggregate reports knowledge.
* Supporting process improvement, implementing, and maintaining processes.
* Responsible for the Aggregate Reports Master Schedule and worldwide legislation overview.
* Collaborating with the PV Scientist lead to coordinate and author 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.
Requirements
* A Master's degree or higher in Life Sciences or a related field.
* 8+ years of work experience in PV with strong focus on authoring aggregate reports.
* 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, and with external colleagues.
* Represents and speaks to processes in cross-Safety and cross-functional forums.
* Familiarity with Pharmacovigilance and drug development, including knowledge of case processing, expedited reporting rules, and safety database concepts.
* Knowledge of common data processing software and safety database systems.
* Strong communication skills in English and organisational skills.
About the Team
The selected candidate will be part of a dynamic team contributing to the discovery, development, and delivery of innovative therapies to improve patients' lives.
This role offers 100% remote work possibilities from Switzerland.