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Work with us

Traineeship / Internship

Pharmacovigilance Trainee (PV Trainee)

Collect, register, and evaluate all safety information that emerges from PV activities during post-marketing uses of medicinal products.
Full Time

Madrid, Spain

Experience required:

Not required.

Duties required:

  • Management and follow-up of Adverse Events (AEs): report forms, assessment, causality, registration, Quality Control and submission activities meeting the set deadlines.
  • Management and follow-up of the medical information enquiries received: answers, registration, QC and possible AEs detected, sent to the clients meeting the set deadlines.
  • Perform internal training on PV for the company team and external training of the clients according to SOP.
  • Notify the client and the Competent Authorities (CAs) of any AEs meeting the requested due date. Perform (as required) the literature research for the specific substances and trade names for the products included in PV agreements.
  • Support the PV Officer in the preparation of the Risk Management Plans (RMPs) for marketed products.
  • Support the PV Officer in the preparation of the Periodic Safety Update Reports (PSURs) for marketed products.
  • Support the PV Officer in the preparation of safety concerns documentation in relation with the marketing Authorization (MA) applications and renewals.
  • Maintain the PV archiving of the Department.
  • Support in the preparation of the monthly reconciliation reports.

Education and skills required:

  • Degree in Life Sciences or similar.
  • Specific education on PV (Master will be desirable).
  • Working knowledge of Microsoft Office package.
  • English level: fluent

No traineeships or internships available at the moment.

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