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Pharmacovigilance Medical Expert

 

Pharmacovigilance Medical Expert

 

PV-MF Clinical Expert is responsible to provide the required medical expertise in pharmacovigilance processes requesting a clinical evaluation.

Main responsibilities

  • Perform ICSRs medical evaluation

  • Define ADRs relatedness and expectedness

  • Request follow-up information

  • Verify coded medical terms

  • Perform clinical evaluation and review benefit/risk assessment during PSURs preparation

  • Write the section of his/her own pertinence and review Risk Management Plans.

  • Provide all required medical expertise in all phases of the signal management process.

  • Attending the Safety Surveillance Meetings

  • Support EU QPPV of any product Emergency Safety Issues

  • Know and update the safety profile of marketed products

  • Prepare, in collaboration with EU QPPV/PV-MF Manager, the draft of the safety communication

  • Review and signs the Addendum to the Clinical Overview

  • Review and signs the Company Core Safety Information

  • Evaluate, in collaboration with Clinical Development or Corporate & International Medical Affairs/Medical Affairs & Congresses, all medicinal product requests for Compassionate use.

  • Signs the Responsibility Letter for Compassionate/named Patient Use programs as Primary Contact of Alfasigma.

  • Check that the prescription of the medicinal product for Named patient use is complete and compliant to applicable requirements.

  • Evaluation of scientific/medical literature

  • Awareness of the changes in local and international legislation.


Qualifications

  • Medical Doctor

  • MedDRA coder

  • Global safety database user

  • EV/EVDAS user

 

Job location: Bologna

The selection is addressed to candidates of either sex (L.903/77).

Interested candidates are kindly requested to send a detailed Curriculum Vitae, together with the authorization for the treatment of personal data according to GDPR 2016/679

 

Degrees of interest: Medical Doctor

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Important: if the job description is in english, than also the motivation letter and the cv saved into the platform must be in english.


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