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Regulatory/pharmacovigilance manager

Polifarma SpA

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Location:

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Category:
Pharmacy

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Contract Type:
Not provided

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Salary:

Not provided

Job Description:

This professional performs precise tasks aimed at checking legislation and drug safety. The role involves activities related to maintaining the MA and new registrations, even extra-EU, to which activities linked to pharmacovigilance are added. The role also involves archiving and registering documents, producing information on regulatory aspects, and completing paperwork for manufacturing products.

Job Responsibility:

  • Ensure that all information concerning the safety of products after they have obtained marketing authorisation are brought quickly to the attention of health personnel
  • Draft the Periodic Safety Updated Reports (PSURs) and forward reports of suspected serious adverse and unexpected reactions to the national pharmacovigilance system
  • Notify the Pharmacovigilance Office of the Ministry of Health of any initiative adopted by other countries for safety reasons
  • Disseminate information notices and safety updates to prescribers
  • Maintain the MA and new registrations, even extra-EU
  • Activities linked to pharmacovigilance (collection of reports, any insights, database entries, follow-up)
  • Archiving and registering documents
  • Produce information on regulatory aspects in the chemical field
  • Apply techniques for drafting informative reports
  • Complete the paperwork for manufacturing products or apply the administrative procedures for issuing permits, disclaimers and authorisations.

Requirements:

  • Graduate in medicine and surgery or in pharmacy, chemistry and pharmaceutical technology, biology or chemistry
  • Knowledge of clinical trials and quality systems
  • Previous experience in the post
  • Knowledge of national and EU legislation in the field of chemical products
  • Ability to archive and register documents
  • Ability to use data archiving software
  • Ability to produce information on regulatory aspects in the chemical field
  • Ability to apply techniques for drafting informative reports
  • Ability to complete paperwork for manufacturing products or apply administrative procedures for issuing permits, disclaimers and authorisations.

Additional Information:

Job Posted:
December 26, 2025

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