Drug Safety Officer

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7i4cy4

Role: Drug Safety Officer Reports to: Drug Safety Manager Main responsibilities
Ensures that all activities are performed in compliance with applicable pharmacovigilance guidelines and procedures.
Conducts screening of spontaneous adverse event reports in Eudra Vigilance.
Performs literature searches using Pub Med, MLM, and local scientific journals.
Reviews and quality checks results from Eudra Vigilance and literature searches.
Manages data entry of adverse event/adverse drug reaction (AE/ADR) reports in the pharmacovigilance database.
Identifies, verifies, and confirms potential follow-up information and duplicate cases.
Performs checks related to new referral procedures and PSUSA activities.
Supports the preparation of product-related messages within the Extended Eudra Vigilance Medicinal Product Dictionary (XEVMPD).
Assists Drug Safety Specialists in the preparation of aggregate reports (PADERs and PSURs).
Supports Signal Detection Management activities.
Manages electronic and paper archiving of pharmacovigilance documentation and reports.
Contributes to Quality System activities, including deviations, CAPAs, changes, audits, and inspections.
Ensures compliance with data integrity principles across all pharmacovigilance activities.
Technical/Regulatory Skills Required
Good knowledge of pharmacovigilance regulations, including Good Pharmacovigilance Practices (GVP) and relevant Italian and European guidelines
Familiarity with the Eudra Vigilance system,



with the ability to support the entry and management of safety reports under supervision
Good knowledge of the Med DRA dictionary and its use for coding adverse event data
Understanding of fundamental pharmacovigilance principles and key international regulatory requirements
Soft Skills Required
Problem?solving skills with a proactive and solution?oriented approach
Ability to work independently, with appropriate levels of supervision for a junior role
Strong attention to detail and accuracy in performing tasks
Effective interpersonal and communication skills, with the ability to collaborate within the Drug Safety Unit and Regulatory Affairs department
Ability to manage multiple activities simultaneously while respecting deadlines and prioritizing workload effectively
IT Skills Required
Proficiency in Microsoft Office tools (Word, Excel, Power Point)
Proficiency in Adobe Acrobat
Language Skills Required
Italian: Native or professional proficiency both written and spoken (C1)
English: Professional proficiency both written and spoken (B2)
Education
Degree in scientific field, preferably Chemistry and Pharmaceutical Technology
Previous experience in the role or in a similar position within the sector At least 1 year of experience in the field of Pharmacovigilance.
Certifications and Authorizations Degree, preferably in a scientific field (Pharmaceutical Chemistry and Technology, Chemistry, Biotechnology, Biology, etc.)

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7i4cy4