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Part time Pharmacovigilance Assistant (temporary 12 months)

05 mai | Temporaire | 50 – 60%

Debiopharm is an independent biopharmaceutical company based in Switzerland with an ongoing commitment to research in oncology and bacterial infections in order to improving patient outcomes and quality of life. Our main activities include drug development, drug manufacturing and digital health investment. Debiopharm International SA aims to develop innovative therapies that target high unmet medical needs. Bridging the gap between disruptive discovery products and real-world patient reach, we identify high-potential compounds for in-licensing, clinically demonstrate their safety and efficacy and then select large pharmaceutical commercialization partners to maximize patient access globally.

Here: https://apply.workable.com/debiopharm-group-sa/

Debiopharm International S.A. identifies high-potential compounds for in-licensing, conducts clinical development and then selects large pharmaceutical commercialization partners to maximize patient access across the globe.

 

For our Pharmacovigilance organization based at our Headquarters in Lausanne, we are looking for a

Part time Pharmacovigilance Assistant (temporary 12 months)

o support our Pharmacovigilance & Clinical Safety team with extra-activity, we are looking for a Pharmacovigilance Assistant.

Your responsibilities will be but not limited to:

  • Triage and process license partner Individual Case Safety Report (ICSR) CIOMS forms according to the SDEA
  • Check the appropriate implementation of the SDEA and relative documents
  • Support Clinical Safety Officers regarding the TMF filing in the safety database
  • Provide with KPIs in order to monitor SDEA compliance of our different license partners
  • Ensure reconciliation of case reports with licence partners
  • Route /close processed ICSRs to reach the next stage in the Safety Database
  • Track ICSRs
  • Archive of safety information such as case reports and safety correspondence
  • Manage the contract requests for the Pharmacovigilance and the Clinical Safety group
  • Summarize KPI and formulate CAPAs for unmet/delayed KPIs
  • Maintain quality documents
Requirements
  • Commercial diploma (CFC) or equivalent
  • First experience in supporting a Pharmacovigilance department within the Pharmaceutical or/and Medical Devices Industry
  • First Experience in working with a Pharmacovigilance Database
  • Ability to manage multiple and varied tasks and prioritize workload with attention to detail;
  • You are a Team-player, ready to support your colleagues
  • Excellent interpersonal, written and verbal communication skills
  • Fluent English, French is an asset
  • The 50/60% requires presence every day (either morning or afternoon)
Benefits
  • An international and highly dynamic environment, with a long term vision.
  • The opportunity to join a successful company, at the forefront of the most advanced scientific developments in the industry and be exposed to many areas within clinical development and the pharmaceutical industry.
  • The possibility to be in a company in which innovation, people and entrepreneurship are the fundamentals of its success.