PpSENIOR OPERATIONS MANAGER pharmacovigilance – CLINICAL (PRE-MARKETING FOCUS) /p p(Rif. ANN ) /p pWORK LOCATION: Rome; 2 days per week of smart working /p pCONTRACT: Permanent contract; full-time /p pSALARY: Gross Annual Salary between €50,000 and €55,000 + 10% MBO + corporate welfare + meal vouchers /p pThe Company: /p pOur client is an international consulting firm specialized in digital consulting and solutions for the Life Sciences sector, headquartered in Italy and active since 2010. /p pThe company supports pharmaceutical and biotech organizations across regulatory affairs, pharmacovigilance, clinical development, medical affairs, and quality assurance. /p pIt delivers innovative digital tools and high value-added services, with a strong focus on regulatory compliance and operational efficiency, operating in complex international environments. /p h3The Role /h3 pYou will operate with a clear focus on Clinical Safety activities in the pre-marketing (PRE) phase, supporting pharmaceutical and biotech clients during drug development. /p pYou will take strategic and operational responsibility for clinical pharmacovigilance activities across assigned client portfolios, ensuring regulatory compliance and robust safety oversight throughout the development lifecycle. /p pAs a senior figure, you will also act as Deputy to the Head of Function when required, ensuring continuity of leadership and decision-making. /p h3Your Responsibilities /h3 ul liAct as senior pharmacovigilance contact and clinical safety lead for assigned client portfolios during the PRE-marketing phase /li liEnsure oversight of safety surveillance activities within clinical trials, including ongoing benefit–risk evaluation /li liGuarantee compliance with global PV and clinical safety regulations (EU GVP, ICH, MHRA, FDA) during drug development /li liSupervise preparation and submission of key development safety documents (e.g., DSUR, SUSAR reporting) and support regulatory interactions /li liLead signal detection and risk assessment activities within clinical programs /li liOversee development and maintenance of Risk Management Plans in alignment with development strategy /li liEnsure robustness of Pharmacovigilance Systems and inspection readiness for clinical programs /li liLead audits, inspections, CAPA management, and remediation activities related to clinical safety /li liOversee third-party vendors delivering PV and clinical safety services /li liProvide technical leadership to PV teams involved in clinical activities /li liSupport business development initiatives, proposals, and due diligence activities /li liAct as Deputy for the responsible Head, ensuring operational continuity and strategic alignment when required /li /ul h3You may be the right person if: /h3 ul liYou have at least 5 years of experience in Pharmacovigilance with strong exposure to Clinical Safety (pre-marketing phase) /li liYou have solid expertise in ICH guidelines and global PV regulations applicable to drug development /li liYou have experience managing DSURs, SUSAR reporting, signal management, and benefit–risk evaluation in clinical trials /li liYou have experience supporting or leading regulatory inspections and audits /li liYou have experience overseeing PV systems and vendor management /li liYou are fluent in English /li /ul h3The Company Offers: /h3 ul liGross Annual Salary between €50K and €55K + 10% MBO /li liCorporate welfare package and meal vouchers /li liHybrid working model (2 days per week remote working) /li /ul pAll job postings are open to candidates of all genders (L.903/77). /p pTo verify whether the search is still active, please visit and enter the job reference code. /p pSend us your CV even if the selection process is closed: we may contact you for future opportunities. /p pPlease read the privacy notice and authorize the processing of personal data in the application form. /p pRecruitment and Selection – Authorized by MLSPS Prot.13/I/ /p /p #J-18808-Ljbffr