Posturi disponible

PV Development Coordinator

18.2.2019

Job description:

  • Creation and update of new SOPs, according to legislation updates and process improvements, ensure implementation of projects across departments;
  • Ensure implementation of CAPAs;
  • Safety Data Exchange Agreements (SDEAs): negotiation of SDEAs, informing/ training relevant stakeholders on their responsibilities as per SDEA;
  • Due diligence process: legacy data assessment, transfer, timelines;
  • Integration process: integrate the PV system of newly acquired companies into Alvogen’s.

Requirements:

  • English language: advance level (both speaking and writing, good undestanding of medical English terms is a must)
  • Computer skills: very good knowledge of MS Office tools (MS Excel knowledge is a must)
  • Communication skills: highly flexible individual with very good communication skills which can enable system improvement
  • Knowledge of EU pharmacovigilance regulations is a must
  • Other regions PV regulations knowledge is a plus
  • Previous experience in processing ICSRs, PSURs and RMPs is a must
  • Enthusiastic
  • Proactive
  • Team player and also able to perform alone (depending on the project)
  • Open minded and willing to take over new responsabilities if needed
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