Senior Safety Scientist - Freelance - Switzerland

MSI Pharma are working with a leading Pharma organization to hire a Senior Safety Scientist to work an initial 6 month project in Switzerland. The ideal candidate needs to be based in Switzerland but can work from home for a significant proportion of the week

The role;

In the role you will provide safety science and pharmacovigilance support to molecules across the client portfolio. As a group, they are responsible for all aspects of safety science/pharmacovigilance.You will need to develop and maintain an understanding of the safety profile of your assigned product(s) or therapy areas in order to;

• Be responsible for individual and aggregate case reporting activities including ICSR case management, medical review and aggregate reporting
• Contribute to regulatory authority submissions including IND applications, NDAs, MAAs, Variations, Renewals) by reviewing safety data and preparing relevant sections of the filing and submission packages in consultation Global safety lead
• Contributing to risk management activities including preparation and maintenance of CCDS, labelling document maintenance, risk communications, RMP, REMS
• Participate in and provide input for Drug Monitoring Committees or internal monitoring committee meetings

Requirements

• The client are looking for candidates with the following experience;
• Master level degree in a Life Science discipline or PharmD
• 5 years experience in Safety Science
• Experience and strong understanding of Signal Detection, Risk Management & Aggregate reports