Product Surveillance Scientist
Randstad Professionals Switzerland
Schweiz, Neuchâtel, Neuchatel
vor 15 Tg.

For an international tobacco company in Neuchâtel, we are seeking a :

Product Surveillance Scientist

Contract : open ending

Manages assigned post-market safety surveillance activities for all applicable products. Leveraging well-established standards, methods and knowledge acquired in the highly regulated drug environment to the new area of tobacco product assessment requires agility, dealing with ambiguity and learning on the fly skills.

Responsibilities :

  • Ensuring the collection of all adverse event complaints throughout the different collection channels set-up and ensuring timely transfer to the case processing team
  • Acting as a key player for any needed case clarification for case processing activities and managing follow-up requests by liaising with the market
  • Monitoring and tracking of cases requiring submission to local competent authorities and ensuring timely transfer to Regulatory Affairs department
  • Performing regular case monitoring for potential escalation of safety cases of concern to internal stakeholders
  • Organizing and conducting safety trainings for successful implementation of post-market safety surveillance activities
  • Supporting in routine data quality monitoring of safety data received from markets and implementing corrective actions as needed
  • Performing data analysis and producing results to communicate information as needed to internal stakeholders
  • Keeping working documents for operational activities up-to-date
  • Skills and Competencies :

  • Graduated with a BSc or MSc in Life Sciences
  • 3 to 5 years experience of relevant business experience in Life Sciences sector
  • Experience in developing / maintaining Safety processes
  • Good knowledge in EU pharmacovigilance (GVP)
  • Experience in working with Safety Database (e.g. Argus and / or Arisg)
  • Strong verbal and written communication and documentation skills required with high attention to detail
  • Willing and able to work independently in a dynamic corporate organization under pressure of tight deadlines and high expectations with the ability to prioritize the workload with strong time management skills
  • Express technical concepts in a non-technical manner
  • Basic training in coding with MedDRA
  • Please note that a UE27 / AELE nationality or a valid Swiss Work Permit are required for this position due to legal compliance in Switzerland.

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