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Job Title: JUNIOR PHARMACOVIGILANCE ASSOCIATE
Location: Siena - Italy
Department: Clinical

Junior Pharmacovigilance Associate

Philogen S.p.A. would like to hire a Junior Pharmacovigilance Associate. The role will report directly to the Responsible of Pharmacovigilance.

In particular the successful candidate will be responsible for:

  • Collaboration in the assessment, triage and management of SAEs and SUSAR submission (e.g. CIOMS-I form preparation).
  • Collaboration in the preparation and submission of the safety documents (e.g. DSUR and periodic safety reports) in accordance with applicable GCP requirements and legislation.
  • Support in preparation of the Communication and Notification to the Competent Authorities and Ethics Committees.
  • Assistant for the data coding using MedDRA dictionary.
  • Writing of Standard Operation Procedures (SOP) related to the Pharmacovigilance area.
  • Give support in preparation and in updating clinical documents including protocols, amendments, IB’s, interim and final safety reports to ensure regulatory compliance and safety throughout trial.
  • Maintenance and archiving of the paper Trial Master File in collaboration with the CTA.
  • Revision of clinical listings to clean safety data in collaboration with medical manager, CRA and data manager.
  • Support in pharmacovigilance post-marketing activities.

 

The ideal candidate should have:

  • Scientific background
  • Previous experience in Pharmacovigilance activities or a Master degree in Pharmacovigilance.
  • Excellent written, verbal and organizational skills.
  • Strong prioritization skills.
  • Ability to handle multiple projects and stressful situations.
  • Good skills in data analysis.
  • Excellent scientific writing skills and fluency of the English language.

We offer:

A contract and salary proportional to the experience (seniority) of the successful candidate.

Job location:

Siena – Italy

 

Interested candidates are kindly asked to send their Curriculum Vitae to the following e-mail address jobopportunities@philogen.it, specifying the job position of interest authorizing the process of personal data under Italian Legislative Decree 196/03 and General Data Protection EU Regulation (2016/679).

Open Position

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