Drug Safety Officer

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7o4js7

ph3Role: Drug Safety Officer /h3 h3Reports to: Drug Safety Manager /h3 h3Main responsibilities /h3 ul 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 /ul h3Technical/Regulatory Skills Required /h3 ul 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 /ul h3Soft Skills Required /h3 ul 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 /ul h3IT Skills Required /h3 ul liProficiency in Microsoft Office tools (Word, Excel, PowerPoint) /li liProficiency in Adobe Acrobat /li /ul h3Language Skills Required /h3 ul liItalian: Native or professional proficiency both written and spoken (C1) /li liEnglish: Professional proficiency both written and spoken (B2) /li /ul h3Education /h3 ul liDegree in scientific field, preferably Chemistry and Pharmaceutical Technology /li /ul 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 /p #J-*****-Ljbffr

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7o4js7