Medical Safety Associate in Neuchâtel

veröffentlicht:
Ort
Neuchâtel, Neuenburg
Sektor
Life Sciences
Jobtyp
Contract
Referenznummer
8258
Kontakt
Megann Löffler, Basel Professionals IT & Life Sciences
Telefon
058 201 55 50
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Stellenbeschreibung

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.

Requirements : 

  • 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:

Megann Löffler 

Recruiter Life Sciences and Healthcare 

Randstad professionals (SA)

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