International, pharmaceutical company
12 months contract with extension option
About Our Client
Our client, an internationally renowned pharmaceutical company in the Zug area, is recruiting. We are now looking for a Pharmacovigilance Scientist experienced with aggregate reports (authoring and management) starting ideally in March, to join their international team for a period of 12 months.
Depending on the selected candidate's performance and motivation, there is a possibility of an extension or a permanent takeover.
100% remote from inside Switzerland is possible.
Job Description
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, and local reports in collaboration with the PV Scientist Lead
Acting as a SME on relevant safety requirements and company policies/procedures related to pharmacovigilance activities, as well as aggregate reports knowledge
Supporting process improvement; implementing and maintaining processes
Ideally responsible for the Aggregate Reports Master Schedule and worldwide legislation overview (production, update, stakeholders review)
In collaboration with the 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
The Successful Applicant
In order to be considered for the role, the selected candidate must have:
Master's degree or degree in Life Sciences or related field
8+ years work experience in PV, including a strong focus on authoring aggregate reports (minimum 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-functionally (including Safety, Clinical Development, Medical Affairs, Clinical Operations, and Regulatory), as well as with external colleagues
Representing and speaking 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, including 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 organizational skills
What's on Offer
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.
100% remote from Switzerland is possible.
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