Drug Safety Officer
pACS DOBFAR S.p.A. multinazionale italiana leader nella produzione di API e Prodotti Finiti, è alla ricerca di una figura motivata e orientata alla qualità da inserire nel team di Pharmacovigilance come bDrug Safety Officer /b. /p pLa risorsa sarà coinvolta in attività chiave legate alla gestione della sicurezza dei farmaci e alla compliance regolatoria, collaborando attivamente con team multidisciplinari in un contesto altamente regolato e internazionale. /p h3Il profilo ideale possiede: /h3 ul lialmeno 1 anno di esperienza in Pharmacovigilance /li libuona conoscenza delle normative GVP, EudraVigilance e MedDRA /li lilaurea in discipline scientifiche (preferibilmente Farmacia o CTF) /li liottime capacità organizzative, attenzione al dettaglio e attitudine al problem solving /li /ul pLa posizione rappresenta un’interessante opportunità di crescita professionale in un ambiente agile e strutturato, con coinvolgimento in attività di case management, screening della letteratura, signal detection, reportistica aggregata e processi di qualità. /p pLa posizione è full-time presso gli uffici di Agrate Brianza con possibilità di 10 giorni di smart working al mese. /p pPer questa selezione verranno considerati solo candidati/e domiciliati nelle vicinanze di Agrate Brianza. /p h3Role: Drug Safety Officer /h3 h3Reports to: Drug Safety Manager /h3 h3Main responsibilities: /h3 ol liEnsures that all activities are performed in compliance with applicable pharmacovigilance guidelines and procedures. /li liConducts screening of spontaneous adverse event reports in EudraVigilance. /li liPerforms literature searches using PubMed, MLM, and local scientific journals.
/li liReviews and quality checks results from EudraVigilance and literature searches. /li liManages data entry of adverse event/adverse drug reaction (AE/ADR) reports in the pharmacovigilance database. /li liIdentifies, verifies, and confirms potential follow-up information and duplicate cases. /li liPerforms checks related to new referral procedures and PSUSA activities. /li liSupports the preparation of product-related messages within the Extended EudraVigilance Medicinal Product Dictionary (XEVMPD). /li liAssists Drug Safety Specialists in the preparation of aggregate reports (PADERs and PSURs). /li liSupports Signal Detection Management activities. /li liManages electronic and paper archiving of pharmacovigilance documentation and reports. /li liContributes to Quality System activities, including deviations, CAPAs, changes, audits, and inspections. /li liEnsures compliance with data integrity principles across all pharmacovigilance activities. /li /ol h3Technical/Regulatory Skills Required: /h3 ol liGood knowledge of pharmacovigilance regulations, including Good Pharmacovigilance Practices (GVP) and relevant Italian and European guidelines /li liFamiliarity with the EudraVigilance system,
with the ability to support the entry and management of safety reports under supervision /li liGood knowledge of the MedDRA dictionary and its use for coding adverse event data /li liUnderstanding of fundamental pharmacovigilance principles and key international regulatory requirements /li /ol h3Soft Skills Required: /h3 ol liProblem-solving skills with a proactive and solution-oriented approach /li liAbility to work independently, with appropriate levels of supervision for a junior role /li liStrong attention to detail and accuracy in performing tasks /li liEffective interpersonal and communication skills, with the ability to collaborate within the Drug Safety Unit and Regulatory Affairs department /li liAbility to manage multiple activities simultaneously while respecting deadlines and prioritizing workload effectively /li /ol h3IT Skills Required: /h3 ol liProficiency in Microsoft Office tools (Word, Excel, PowerPoint) /li liProficiency in Adobe Acrobat /li /ol h3Language Skills Required: /h3 ol liItalian: Native or professional proficiency both written and spoken (C1) /li liEnglish: Professional proficiency both written and spoken (B2) /li /ol h3Education: /h3 ol liDegree in scientific field, preferably Chemistry and Pharmaceutical Technology /li /ol h3Previous experience in the role or in a similar position within the sector: /h3 pAt least 1 year of experience in the field of Pharmacovigilance. /p h3Certifications and Authorizations: /h3 pDegree, preferably in a scientific field (Pharmaceutical Chemistry and Technology, Chemistry, Biotechnology, Biology, etc.) /p #J-18808-Ljbffr
/li liReviews and quality checks results from EudraVigilance and literature searches. /li liManages data entry of adverse event/adverse drug reaction (AE/ADR) reports in the pharmacovigilance database. /li liIdentifies, verifies, and confirms potential follow-up information and duplicate cases. /li liPerforms checks related to new referral procedures and PSUSA activities. /li liSupports the preparation of product-related messages within the Extended EudraVigilance Medicinal Product Dictionary (XEVMPD). /li liAssists Drug Safety Specialists in the preparation of aggregate reports (PADERs and PSURs). /li liSupports Signal Detection Management activities. /li liManages electronic and paper archiving of pharmacovigilance documentation and reports. /li liContributes to Quality System activities, including deviations, CAPAs, changes, audits, and inspections. /li liEnsures compliance with data integrity principles across all pharmacovigilance activities. /li /ol h3Technical/Regulatory Skills Required: /h3 ol liGood knowledge of pharmacovigilance regulations, including Good Pharmacovigilance Practices (GVP) and relevant Italian and European guidelines /li liFamiliarity with the EudraVigilance system,
with the ability to support the entry and management of safety reports under supervision /li liGood knowledge of the MedDRA dictionary and its use for coding adverse event data /li liUnderstanding of fundamental pharmacovigilance principles and key international regulatory requirements /li /ol h3Soft Skills Required: /h3 ol liProblem-solving skills with a proactive and solution-oriented approach /li liAbility to work independently, with appropriate levels of supervision for a junior role /li liStrong attention to detail and accuracy in performing tasks /li liEffective interpersonal and communication skills, with the ability to collaborate within the Drug Safety Unit and Regulatory Affairs department /li liAbility to manage multiple activities simultaneously while respecting deadlines and prioritizing workload effectively /li /ol h3IT Skills Required: /h3 ol liProficiency in Microsoft Office tools (Word, Excel, PowerPoint) /li liProficiency in Adobe Acrobat /li /ol h3Language Skills Required: /h3 ol liItalian: Native or professional proficiency both written and spoken (C1) /li liEnglish: Professional proficiency both written and spoken (B2) /li /ol h3Education: /h3 ol liDegree in scientific field, preferably Chemistry and Pharmaceutical Technology /li /ol h3Previous experience in the role or in a similar position within the sector: /h3 pAt least 1 year of experience in the field of Pharmacovigilance. /p h3Certifications and Authorizations: /h3 pDegree, preferably in a scientific field (Pharmaceutical Chemistry and Technology, Chemistry, Biotechnology, Biology, etc.) /p #J-18808-Ljbffr