REGULATORY/PHARMACOVIGILANCE MANAGER

This professional, a graduate in medicine and surgery or in pharmacy, chemistry and pharmaceutical technology, biology or chemistry performs precise tasks aimed at checking legislation and drug safety:

• ensures that all information concerning the safety of products after they have obtained marketing authorisation, are brought quickly to the attention of health personnel, also by means of contacts from the scientific information service of their company.
• drafts the Periodic Safety Updated Reports (PSURs) and forwards reports of suspected serious adverse and unexpected reactions to the national pharmacovigilance system.
• notifies the Pharmacovigilance Office of the Ministry of Health of any initiative adopted by other countries in which the drug is marketed to their products for safety reasons.
• disseminates information notices and safety updates to prescribers of their drugs every time there is new information on the product’s tolerability profile.

The deadlines and procedures for executing these tasks shall be established by the Directorate General for the Evaluation of Medicinal Products and Pharmacovigilance of the Ministry of Health, in addition to each company's Standard Operational Procedures (SOP).

REGULATORY/PHARMACOVIGILANCE ASSISTANT

This professional figure has knowledge of clinical trials and quality systems, as well as previous experience in the post.
The role involves activities related to maintaining the MA and new registrations, even extra-EU, to which activities linked to pharmacovigilance (collection of reports, any insights, database entries, follow-up) are added.

SECRETARIAT

The role involves archiving and registering documents, or knowing how to apply such methods and procedures and using data archiving software. Produce information on regulatory aspects in the chemical field and apply techniques for drafting informative reports. Know the national and EU legislation in the field of chemical products.
Complete the paperwork for manufacturing products or knowing how to apply the administrative procedures for issuing permits, disclaimers and authorisations.