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Specialist Clinical Safety

Specialist Clinical Safety

CencoraMadrid, Comunidad de Madrid, España
Hace más de 30 días
Descripción del trabajo

Overview

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!

Job Details

PV specialist – Clinical Safety

We have an exciting opportunity for a PV Specialist to join our Clinical Safety team! This role can be based remotely in Spain and we are, above all else, looking for an individual who is motivated and enthusiastic to grow with our Pharmalex brand which has seen great success.

Responsibilities

  • Management of SAEs / AESIs / pregnancies
  • Assure all parties are informed as required & querying the sites when needed; follow the whole process for each case / remind parties of pending information when applicable.
  • Initial triage (assessment of expectedness / seriousness) of SAEs.
  • Data Entry in safety database
  • Narrative writing
  • Support Safety Manager with Review of cases in safety database (QC)
  • Preparation of Line Listings
  • Maintaining annual plans for LLs / DSURs and distribution lists.
  • Safety submissions.
  • Maintenance of trackers and other administrative activities.

Skills

  • Team-oriented approach
  • Organizational skills, ability to multi-task. Ability to assimilate and analyse information rapidly.
  • High sense of responsibility and self-motivation
  • Highly service-oriented
  • Flexibility and adaptability to adjust rapidly to new, unknown, challenging situations.
  • Fluent written and spoken English skills.
  • Excellent written and verbal communication skills.
  • Experience / Background

  • Successful completion of a Bachelor’s degree in medical, natural sciences or pharmacy-related field or Degree in Medicine
  • At least 1 year of relevant professional experience in the field of Pharmacovigilance.
  • Knowledge of safety databases (Argus, Safety Easy are preferred)
  • Experience in case management activities
  • Previous experience in pre-authorisation area.
  • What Cencora offers

    Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements.

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