Drug Safety Officer

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7904u9

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 comestrong Drug Safety Officer. /strong /pp

La 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/pp

Il profilo ideale possiede: /pp✔ almeno 1 anno di esperienza in Pharmacovigilance /pp✔ buona conoscenza delle normative GVP, Eudra

Vigilance e MedDRA /pp✔ laurea in discipline scientifiche (preferibilmente Farmacia o CTF) /pp✔ ottime capacità organizzative, attenzione al dettaglio e attitudine al problem solving /ppbr/pp

La posizione rappresenta un’interessante opportunità di crescita professionale in un atmosfera dinamico e strutturato, con coinvolgimento in attività di case management, screening della letteratura, signal detection, reportistica aggregata e processi di qualità. /ppbr/pp

Se 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/ppstrong

La posizione è full-time presso gli uffici di Agrate Brianza con possibilità di 10 giorni di smart working al mese. /strong /ppbr/ppstrong

Per questa selezione verranno considerati solo candidati/e domiciliati nelle vicinanze di Agrate Brianza. /strong /ppbr/ppu

Role: Drug Safety Officer /u /ppu

Reports to: Drug Safety Manager /u /ppbr/ppstrong

Main responsibilities: /strong /ppbr/polli

Ensures that all activities are performed in compliance with applicable pharmacovigilance guidelines and procedures. /lili





Conducts screening of spontaneous adverse event reports in Eudra

Vigilance. /lili

Performs literature searches using Pub

Med, MLM, and local scientific journals. /lili

Reviews and quality checks results from Eudra

Vigilance and literature searches. /lili

Manages data entry of adverse event/adverse drug reaction (AE/ADR) reports in the pharmacovigilance database. /lili

Identifies, verifies, and confirms potential follow-up information and duplicate cases. /lili

Performs checks related to new referral procedures and PSUSA activities. /lili

Supports the preparation of product-related messages within the Extended Eudra

Vigilance Medicinal Product Dictionary (XEVMPD). /lili

Assists Drug Safety Specialists in the preparation of aggregate reports (PADERs and PSURs). /lili

Supports Signal Detection Management activities. /lili

Manages electronic and paper archiving of pharmacovigilance documentation and reports. /lili

Contributes to Quality System activities, including deviations, CAPAs, changes, audits, and inspections. /lili

Ensures compliance with data integrity principles across all pharmacovigilance activities. /li /olpbr/ppstrong

Technical/Regulatory Skills Required: /strong /ppbr/polli

Good knowledge of pharmacovigilance regulations, including Good Pharmacovigilance Practices (GVP) and relevant Italian and European guidelines /lili

Familiarity with the Eudra

Vigilance system,



with the ability to support the entry and management of safety reports under supervision /lili

Good knowledge of the MedDRA dictionary and its use for coding adverse event data /lili

Understanding of fundamental pharmacovigilance principles and key international regulatory requirements /li /olpbr/ppstrong

Soft Skills Required: /strong /ppbr/polli

Problem-solving skills with a proactive and solution-oriented approach /lili

Ability to work independently, with appropriate levels of supervision for a junior role /lili

Strong attention to detail and accuracy in performing tasks /lili

Effective interpersonal and communication skills, with the ability to collaborate within the Drug Safety Unit and Regulatory Affairs department /lili

Ability to manage multiple activities simultaneously while respecting deadlines and prioritizing workload effectively /li /olpbr/ppstrongIT Skills Required: /strong /ppbr/polli

Proficiency in Microsoft Office tools (Word, Excel, Power

Point) /lili

Proficiency in Adobe Acrobat /li /olpbr/ppstrong

Language Skills Required: /strong /ppbr/polli

Italian: Native or professional proficiency both written and spoken (C1) /lili

English: Professional proficiency both written and spoken (B2) /li /olpbr/ppstrong

Education: /strong /ppbr/polli

Degree in scientific field, preferably Chemistry and Pharmaceutical Technology /li /olpbr/ppstrong

Previous experience in the role or in a similar position within the sector: /strong /ppbr/pp

At least 1 year of experience in the field of Pharmacovigilance. /ppbr/ppstrong

Certifications and Authorizations: /strong /ppbr/pp

Degree, preferably in a scientific field (Pharmaceutical Chemistry and Technology, Chemistry, Biotechnology, Biology, etc.) /p

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7904u9