Technical Drug Safety Officer

hace 4 días

Barcelona, Barcelona, España Grifols A tiempo completo

We are a global healthcare company with a presence in over 110 countries, and a growing team of over 20,000 people.

Grifols is a leader in plasma-derived medicines and transfusion medicine, and we are committed to equal employment opportunities that foster an inclusive environment.

We are seeking a Technical Drug Safety Officer to provide operational support for global pharmacovigilance activities for Grifols investigational and marketed products.

The successful candidate will ensure pharmacovigilance deliverables are of the highest quality and meet global regulatory reporting timelines.

Key responsibilities will include:

  • Participating in the safety data collection, review, processing, evaluation, analysis, and compilation.
  • Processing Grifols marketed products adverse event case reports, including definition of submissions required and conducting follow-up with reporters.
  • Reviewing the weekly literature search and updates in pharmacovigilance legislation.
  • Complying with archiving tasks for deliverables and relevant documents.
  • Compiling information for and participating in the preparation of periodic safety update reports.
  • Supporting the pharmacovigilance staff involved in audits and inspections.
  • Providing training to concerned personnel based on the training plan and managing training documentation and deliverables within relevant company departments.
  • Supporting the review and update of SOPs, working practices, or conventions.
  • Using queries for data extraction for different PV documents.
  • Ensuring data consistency and integrity within the safety database.
  • Supporting updates in the database configuration.

The ideal candidate will have a Bachelor's degree in life science and be fluent in written and spoken English (C1 Advanced) and Spanish. Having proficiency in additional languages such as Chinese, Italian, French, or others will be highly valued.

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