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

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- 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

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- 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

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- 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
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IT Skills Required

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- Proficiency in Microsoft Office tools (Word, Excel, PowerPoint)

- Proficiency in Adobe Acrobat

Language Skills Required

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- Italian: Native or professional proficiency both written and spoken (C1)

- English: Professional proficiency both written and spoken (B2)

Education

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- 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)
🏢 ACS DOBFAR
📍 Agrate Brianza