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ACS DOBFAR
Drug Safety OfficerACS DOBFAR • Agrate Brianza, Italy
Drug Safety Officer

Drug Safety Officer

ACS DOBFAR • Agrate Brianza, Italy
5 giorni fa
Descrizione dell’offerta di lavoro

Role: Drug Safety Officer

Può ottenere maggiori dettagli sulla natura di questa posizione e sui requisiti per i candidati leggendo quanto segue.
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 EudraVigilance.
  • Performs literature searches using PubMed, MLM, and local scientific journals.
  • Reviews and quality checks results from EudraVigilance 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 EudraVigilance 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 EudraVigilance system, with the ability to support the entry and management of safety reports under supervision
  • Good knowledge of the MedDRA 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
    xysqume


IT Skills Required


  • Proficiency in Microsoft Office tools (Word, Excel, PowerPoint)
  • 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.)


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Drug Safety Officer • Agrate Brianza, Italy

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