Freelance/Contract Fachtechnisch verantwortliche Person (FvP) Consultant

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world’s largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

Position overview

We are currently searching for a “Freelance/Contract FvP’ (Fachtechnisch verantwortliche Person)’ to work on a key project with one of our most innovative clients based out of Switzerland. This project will commence in October; it requires 1-2 days per week support and will run for at least one year but most likely longer. The role requires travel to the site in Zug when critical but it can be performed largely remotely but from a permanent location in Switzerland.

In this position, you will act as the ‘Fachtechnisch verantwortliche Person’ for our client and are required to help ensure the license application made is successful and to all key regulations required. Following on from this, you will be named on the license as the official FVP; run batch release activities and are tasked with ensuring their compliance to all necessary regulations throughout the project tenure. This project requires the successful Consultant to have a demonstrated background working as an FVP within a Biological setting.

Qualifications

• A University degree in Science/Engineering is required, preferably MSc in Pharmacy or similar.

• Must be a proven Responsible Person (FVP) in Switzerland

• Advanced knowledge of key regulations within Switzerland related to performing the FVP role

• Fluent in German and English

• Direct exposure to working with Biological projects as an FVP is vital

• Can perform the project as designated above

• Outstanding stakeholder management skills