Medical Safety Officer - Switzerland

You are highly motivated and always committed to deliver work of the highest quality. You encourage collaboration and enjoy working in a team. You are a passionate individual who likes creative and international work environments.

THE OPPORTUNITY

The successful candidate will join the Medical Office of Product Assessment and Scientific Substantiation unit in Neuchâtel (Switzerland).

You will manage and oversee medical safety for all assessment studies within the assessment program for one or more products spanning across multiple functions and pillars (e.g. clinical studies, perception and behavioural studies) pre- and post-market.

You will actively support medical safety surveillance activities occurring pre- and post-market.

You will serve as a technical leader and a key resource to PASS Management and provides expertise in Medical Safety.

Specifically, you will:

*Plan, implement and execute state of the art safety monitoring activities in compliance with applicable ICH, regulatory and legal requirements as well as scientific standards.
*Establish implement and maintain medical safety related policies, procedures and programs related to assessment studies in humans and have a key role for interactions with medical safety partners/vendors
*Be accountable for the management, assessment, processing and communication/reporting of safety information, such as expedited and periodic safety reports. Develop all state of the art safety related documentation
*Guide the clinical study teams, external partners and internal stakeholders on medical safety matters.



QUALIFICATIONS

*University Degree. Physician with medical doctor diploma (MD board certification)
*Degree in a medical/pharmacology specialty is an asset (such as pharmaceutical medicine, clinical pharmacology, internal medicine, cardiology, physiology, pulmonology, pharmacovigilance)
*Substantial experience in medical safety acquired in industry, CRO and academia. The experience should mainly be focused on methods, processes, assessment and reporting used in the area of the scientific/clinical/medical aspects in clinical studies
*Additional expertise gained through education, experience and training in at least one of the following domains: pharmaceutical medicine, pharmacovigilance, clinical pharmacology, pharmacokinetics
*Sound knowledge with regards to safety signal detection would be an asset.
*Good knowledge of ICH CGP (track record of GCP trainings)
*Fluency in spoken and written English
*Experience in working in a project-oriented, deadline-driven team environment

WHAT WE OFFER

You will be part of the Research & Development Department, You will benefit from our dynamic team of professionals, working in a multicultural environment.

We offer an excellent salary and benefits package as well as a relocation allowance (where appropriate).

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