Overview
Global Safety Specialist Jobs in Tirana, Albania at Dompé
Title: Global Safety Specialist
Company: Dompé
Location: Tirana, Albania
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
.
Responsibiliti
- es: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 lifecyc
- le.Ensure collection, classification, control and electronic storage of Individual Case Safety Reports (ICSRs) from any sour
- ce.Access to EudraVigilance (EV), based on the assigned role, in order to download, intake and report ICS
- Rs.Assess reportability of ICS
- Rs.Ensure case processing of ICSRs in the safety database, including follow up request manageme
- nt.Ensure the preparation of individual reports (ICSRs and SUSARs) for regulatory submission and/or notification to the partne
- rs.Ensure timely regulatory submission of ICSRs to regulatory Authority and Partne
- rs.Ensure monitoring, tracking and documenting of national and international scientific literatu
- re.Provide back up support to Dompé GPS2 upon reque
- st.Ensure collection and management of reports of adverse events associated with other Company products (medical device, food supplements, cosmetic
- s).Participate and provide support during audit or regulatory inspections at global lev
- el.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 informati
- on.Be aware and act in compliance with the relevant law, ethics and regulations and corporate procedures of the reference ar
ea.
Qualifica
- tions
University Degree: Life S
cience
Require
- d SkillsGood computer skills, including MS Office (Excel, Powe
- r Point)Fluently in English and Italian Language (written and
- spoken)Knowledge of applicable pharmacovigilan
- ce rulesKnowledge of the MedD
- RA toolsKnowledge and use of company pharmacovigilance
- databaseCertification as EudraVigilance user (European database of adverse drug re
- actions)Good communication skills, proactivity, teamworking, flexible thinking, i
- ntegrityGood organization skills, independent in performing the duties and in coordinati
ng teams
Preferr
- ed Skills:
Optional: previous working experience in the role, knowledge of European law requirements in pharmacovigilance or Vigilance ce
rtification
