Medical Safety Officer
Medical Safety Officerin Neuchâtelveröffentlicht: Dienstag, 27. September 2016
KontaktFilipa Lessa, Basel Professionals IT & Life Sciences
Telefon058 201 55 50
StellenbeschreibungOur client in Neuchatel area is looking for
Medical Safety OfficerLocation: Neuchatel, Switzerland Contract: 1 year with possibility of extension Start date: December 2016 Job description: - MSO for one or more of platforms/assigned clinical studies for planning, implementation and execution of all state of art safety monitoring activities in compliance with industry operating processes and all applicable ICH, regulatory and legal requirements as well as scientific standards.
- Establish and implement medical safety related policies, procedure and programs related to assigned assessment studies in humans and has leadership role in collaboration with strategic partners for medical safety.
- Accountable for the management, assessment, processing and communication of all serious adverse events and events of interest subjects to expedited reporting occurring in assessment studies, including the preparation of case reporting to the respective authorities and institutional review boards/ethic committees within timelines set by local authorities.
- Guide the clinical study teams, external partners and internal stakeholders with regards to questions related medical safety in assessment studies
- Actively contribute to the clinical assessment team duties, such as maintenance and improvement of processes, GCP trainings, and managerial reporting.
- Establish and maintain close relationship with regulatory and scientific affairs to ensure close collaboration and efficient processing and reporting safety cases to regulatory authorities
- Physician with medical doctor diploma
- Degree in medical/pharmacology specialty an asset (such as pharmaceutical medicine, clinical pharmacology, internal medicine, pharmacovigilance)
- ≥ 5 years experience in medical safety (industry, CRO or academia) primarily from clinical studies in phama/medical device or cosmetic
- Experience in medical monitoring of clinical studies
- Knowledge in signal detection and data analysis
- English fluent
- Efficiency: results-oriented, organizational skills, able to set priorities and to deliver on time, problem solving, high flexibility and ability to work independently. We are looking forward to receiving within your application: - your CV in English - latest Work Certificates - your Motivation Letter - the date of your availability Apply now to be considered – Good to know you!
For more information and your application, please contact: Barbara Sorce Professionals Life Sciences Consultant Randstad (Suisse) SA T: +41 58 201 55 64 M:+41 79 376 00 71 firstname.lastname@example.org