Pharmacovigilance (AE Intake) Specialist, Italian and English speaker

  • Full time
  • Prague
  • Posted 2 weeks ago

We are looking for the best talent, with Italian and English language expertise to be part of a global team that partnership with a major pharmaceutical company, working with patient safety on post-market products.

Apply your knowledge and expertise, including complex decision making, to review, assess and process safety and product quality information.

Summary:

Review,assess and process safety data and information, across service lines, received from various sources and distribute reports/data onwards to both internal and external third parties, following applicable regulations SOPs and internal guidelines under guidance and support of senior operation team members.

Key responsibilities:

  • To Prioritize and complete the assigned trainings on time.

  • Receiving, reviewing and interpretation of medical report.

  • Process safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements.

  • To perform Pharmacovigilance activities per project requirement including but not limited to, collecting and tracking incoming.

  • AdverseEvents(AE)/endpoint information.

  • Determining initial/update status of incoming events.

  • Database entry.

  • Coding AE and Products, writing narratives, Literature related activities as per internal/ project timelines.

  • Ensure to meet quality standards per project requirements.

  • Ensure to meet productivity and delivery standards per project requirements.

  • To ensure compliance to all project related processes and activities.

  • Creating, maintaining and tracking cases as applicable to the project plan.

  • Identify quality problems, if any, and bring them to the attention of a senior team member.

  • To demonstrate problem solving capabilities.

  • Attend project team meetings and provide feedback to operations manager on any challenges/issues or successes.

  • 100% compliance towards all people practices and processes.

  • Minimum Required Education and Experience

  • Must be native/C2 level Italian and fluent in English language.

  • Bachelor’s Degreein scientific or healthcare area.

  • Skills and Abilities

  • Excellent attention to detail and accuracy.

  • Good knowledge of medical terminology.

  • Working knowledge of applicable Safety Database.

  • Self-motivated and flexible.

  • Ability to follow instructions/guidelines, utilize initiative and work independently.

  • To apply for this job please visit cz.talent.com.