Drug Safety Officer

ACS DOBFAR; Agrate Brianza; In loco; EUR 35.000 - 50.000; Tempo pieno

Descrizione del lavoro

ACS DOBFAR is looking for a Drug Safety Officer in Agrate Brianza, Italy. The ideal candidate will ensure compliance with pharmacovigilance guidelines, manage data entry of adverse event reports, and support product-related documentation. A degree in a scientific field is necessary along with at least one year of pharmacovigilance experience.

Soft skills such as problem-solving, attention to detail, and effective communication are essential. The role requires proficiency in Italian and English. Candidates will benefit from a collaborative environment within the Drug Safety Unit.

Competenze

• At least 1 year of experience in the field of Pharmacovigilance.
• Native or professional proficiency in Italian (C1), professional proficiency in English (B2).

Mansioni

• Ensure compliance with pharmacovigilance guidelines.
• Conduct screening of adverse event reports.
• Perform literature searches and data entry of reports.
• Support preparation of product-related messages.

Conoscenze

Good knowledge of pharmacovigilance regulations

Problem-solving skills

Effective interpersonal and communication skills

Proficiency in Microsoft Office tools

Proficiency in Adobe Acrobat

Formazione

Degree in scientific field (Chemistry and Pharmaceutical Technology)

Descrizione del lavoro

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 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

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.)