Drug Safety Officer

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7l4ch0

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 comeb Drug Safety Officer. /b /ppLa 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. /ppbr/ppIl profilo ideale possiede: /pp✔ almeno 1 anno di esperienza in Pharmacovigilance /pp✔ buona conoscenza delle normative GVP, EudraVigilance e MedDRA /pp✔ laurea in discipline scientifiche (preferibilmente Farmacia o CTF) /pp✔ ottime capacità organizzative, attenzione al dettaglio e attitudine al problem solving /ppbr/ppLa posizione rappresenta un’interessante opportunità di crescita professionale in un ambiente vivace e strutturato, con coinvolgimento in attività di case management, screening della letteratura, signal detection, reportistica aggregata e processi di qualità. /ppbr/ppSe sei interessato/a o conosci qualcuno in linea con questa opportunità, inviaci la tua candidatura tramite questo annuncio o sul sito di ACS nella pagina "careers". /ppbr/ppbLa posizione è full-time presso gli uffici di Agrate Brianza con possibilità di 10 giorni di smart working al mese. /b /ppbr/ppbPer questa selezione verranno considerati solo candidati/e domiciliati nelle vicinanze di Agrate Brianza. /b /ppbr/ppRole: Drug Safety Officer /ppReports to: Drug Safety Manager /ppbr/ppbMain responsibilities: /b /ppbr/pulliEnsures that all activities are performed in compliance with applicable pharmacovigilance guidelines and procedures.



/liliConducts screening of spontaneous adverse event reports in EudraVigilance. /liliPerforms literature searches using PubMed, MLM, and local scientific journals. /liliReviews and quality checks results from EudraVigilance and literature searches. /liliManages data entry of adverse event/adverse drug reaction (AE/ADR) reports in the pharmacovigilance database. /liliIdentifies, verifies, and confirms potential follow-up information and duplicate cases. /liliPerforms checks related to new referral procedures and PSUSA activities. /liliSupports the preparation of product-related messages within the Extended EudraVigilance Medicinal Product Dictionary (XEVMPD). /liliAssists Drug Safety Specialists in the preparation of aggregate reports (PADERs and PSURs). /liliSupports Signal Detection Management activities. /liliManages electronic and paper archiving of pharmacovigilance documentation and reports. /liliContributes to Quality System activities, including deviations, CAPAs, changes, audits, and inspections. /liliEnsures compliance with data integrity principles across all pharmacovigilance activities. /li /ulpbr/ppbTechnical/Regulatory Skills Required: /b /ppbr/pulliGood knowledge of pharmacovigilance regulations, including Good Pharmacovigilance Practices (GVP)



and relevant Italian and European guidelines /liliFamiliarity with the EudraVigilance system, with the ability to support the entry and management of safety reports under supervision /liliGood knowledge of the MedDRA dictionary and its use for coding adverse event data /liliUnderstanding of fundamental pharmacovigilance principles and key international regulatory requirements /li /ulpbr/ppbSoft Skills Required: /b /ppbr/pulliProblem-solving skills with a proactive and solution-oriented approach /liliAbility to work independently, with appropriate levels of supervision for a junior role /liliStrong attention to detail and accuracy in performing tasks /liliEffective interpersonal and communication skills, with the ability to collaborate within the Drug Safety Unit and Regulatory Affairs department /liliAbility to manage multiple activities simultaneously while respecting deadlines and prioritizing workload effectively /li /ulpbr/ppbIT Skills Required: /b /ppbr/pulliProficiency in Microsoft Office tools (Word, Excel, PowerPoint) /liliProficiency in Adobe Acrobat /li /ulpbr/ppbLanguage Skills Required: /b /ppbr/pulliItalian: Native or professional proficiency both written and spoken (C1) /liliEnglish: Professional proficiency both written and spoken (B2) /li /ulpbr/ppbEducation: /b /ppbr/pulliDegree in scientific field, preferably Chemistry and Pharmaceutical Technology /li /ulpbr/ppbPrevious experience in the role or in a similar position within the sector: /b /ppbr/ppAt least 1 year of experience in the field of Pharmacovigilance. /ppbr/ppbCertifications and Authorizations: /b /ppbr/ppDegree, preferably in a scientific field (Pharmaceutical Chemistry and Technology, Chemistry, Biotechnology, Biology, etc.) /p

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7l4ch0