About the job

Dompé is an Biopharmaceutical company driven by innovation and research, with headquarters in Milan and operations across Europe and the United States. The company focuses on developing and delivering therapeutic solutions in areas of high unmet medical need, combining scientific excellence, digital innovation, and a strong commitment to improving patients’ lives.

For our office in Tirana we are looking for an Global Safety Specialist.

Responsibilities:

• Ensure the regular and continuous management of pharmacovigilance activities in terms of processing of Individual Case Safety Reports and maintaining the products safety monitoring through their lifecycle.
• Ensure collection, classification, control and electronic storage of Individual Case Safety Reports (ICSRs) from any source.
• Access to EudraVigilance (EV), based on the assigned role, in order to download, intake and report ICSRs.
• Assess reportability of ICSRs.
• Ensure case processing of ICSRs in the safety database, including follow up request management.
• Ensure the preparation of individual reports (ICSRs and SUSARs) for regulatory submission and/or notification to the partners.
• Ensure timely regulatory submission of ICSRs to regulatory Authority and Partners.
• Ensure monitoring, tracking and documenting of national and international scientific literature.
• Provide back up support to Dompé GPS2 upon request.
• Ensure collection and management of reports of adverse events associated with other Company products (medical device, food supplements, cosmetics).
• Participate and provide support during audit or regulatory inspections at global level.
• Ensure the assessment, monitoring, and documentation of Product Quality Complaints from a pharmacovigilance perspective, aimed at identifying Individual Case Safety Reports or other safety-relevant information.
• Be aware and act in compliance with the relevant law, ethics and regulations and corporate procedures of the reference area.

Qualifications

• University Degree: Life Science

Required Skills

• Good computer skills, including MS Office (Excel, Power Point)
• Fluently in English and Italian Language (written and spoken)
• Knowledge of applicable pharmacovigilance rules
• Knowledge of the MedDRA tools
• Knowledge and use of company pharmacovigilance database
• Certification as EudraVigilance user (European database of adverse drug reactions)
• Good communication skills, proactivity, teamworking, flexible thinking, integrity

About the job

Dompé is an Biopharmaceutical company driven by innovation and research, with headquarters in Milan and operations across Europe and the United States. The company focuses on developing and delivering therapeutic solutions in areas of high unmet medical need, combining scientific excellence, digital innovation, and a strong commitment to improving patients’ lives.

For our office in Tirana we are looking for an Global Safety Specialist.

Responsibilities:

• Ensure the regular and continuous management of pharmacovigilance activities in terms of processing of Individual Case Safety Reports and maintaining the products safety monitoring through their lifecycle.
• Ensure collection, classification, control and electronic storage of Individual Case Safety Reports (ICSRs) from any source.
• Access to EudraVigilance (EV), based on the assigned role, in order to download, intake and report ICSRs.
• Assess reportability of ICSRs.
• Ensure case processing of ICSRs in the safety database, including follow up request management.
• Ensure the preparation of individual reports (ICSRs and SUSARs) for regulatory submission and/or notification to the partners.
• Ensure timely regulatory submission of ICSRs to regulatory Authority and Partners.
• Ensure monitoring, tracking and documenting of national and international scientific literature.
• Provide back up support to Dompé GPS2 upon request.
• Ensure collection and management of reports of adverse events associated with other Company products (medical device, food supplements, cosmetics).
• Participate and provide support during audit or regulatory inspections at global level.
• Ensure the assessment, monitoring, and documentation of Product Quality Complaints from a pharmacovigilance perspective, aimed at identifying Individual Case Safety Reports or other safety-relevant information.
• Be aware and act in compliance with the relevant law, ethics and regulations and corporate procedures of the reference area.

Qualifications

• University Degree: Life Science

Required Skills

• Good computer skills, including MS Office (Excel, Power Point)
• Fluently in English and Italian Language (written and spoken)
• Knowledge of applicable pharmacovigilance rules
• Knowledge of the MedDRA tools
• Knowledge and use of company pharmacovigilance database
• Certification as EudraVigilance user (European database of adverse drug reactions)
• Good communication skills, proactivity, teamworking, flexible thinking, integrity
• Good organization skills, independent in performing the duties and in coordinating teams

Preferred Skills:

• Optional: previous working experience in the role, knowledge of European law requirements in pharmacovigilance or EudraVigilance certification