Our client, a leading international tobacco company, with seven of world’s top 15 brands, including the world’s number one brand is looking for a
Medical Safety Associate
Location: Neuchâtel, Switzerland
Contract: 1 year contract with possibility of extension
Department: Product Safety Surveillance
Start date: as soon as possible
Job Description :
- Support the product safety surveillance function for accurate document management, safety document quality checks, project management, tracking of safety documents, maintenance of processes, safety training, etc.
- Make recommendations for efficiency improvements
- Technical lead for development and maintainance of tracking tools relevant to products mapping along the product life cycle (clinical studies, pre- and postmarket surveillance). Make recommendations and setting guidelines and working procedures for process optimization
- Contribution to case processing (triage, assessment), including case corrections, versioning and nullification.
- Develop and maintain processes for individual case management in regard to accurate workflow, document management, document quality checks, project management, tracking of safety documentation
- Maintain the product safety surveillance workpoint(s) or similar central information repository to ensure information flow and business continuity
- Contribute into and provide support to life cycle of the Product Safety Surveillance quality system
- Deliver assigned safety surveillance activities, assigned safety activities occurring in clinical studies, and serves as a key resource to the Product Safety Surveillance Department (PSSD).
- Independently apply technical practices, procedures and/or theory and has a general understanding of medical safety surveillance / pharmacovigilance and project management processes.
- Responsibilities include, under the control of a supervisor, the maintenance of requirements and processes related to safety monitoring and safety surveillance as well as the management of corresponding documentation.
- MSc in life science or equivalent, PhD is a plus
- 3 years experience in medical safety/pharmacovigilance as safety associate in industry, CRO and/or academia
- Good knowledge in EU pharmacovigilance
- Basic knowledge of CGP and in medical device regulations
- Proficiency in use of safety databases (e.g Argus)
- Experience in medical writing (preparation of DSURs/ PSURs)
- Experience in developing/ maintaining PV processes
- Details oriented, have excellent organisation
- Willing to travel
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:
Recruiter Life Sciences and Healthcare
Randstad professionals (SA)