CPL & TAYLOR by Synergos, ricerca:SENIOR OPERATIONS MANAGER pharmacovigilance– CLINICAL (PRE-MARKETING FOCUS)(Rif. ANN )SEDE DI LAVORO: Rome; 2 days per week of smart workingCONTRATTO: Permanent contract; full-timeRETRIBUZIONE: Gross Annual Salary between €50,000 and €55,000 + 10% MBO + corporate welfare + meal vouchersThe CompanyOur client is an international consulting firm specialized in digital consulting and solutions for the Life Sciences sector, headquartered in Italy and active since 2010.The company supports pharmaceutical and biotech organizations across regulatory affairs, pharmacovigilance, clinical development, medical affairs, and quality assurance.It delivers innovative digital tools and high value-added services, with a strong focus on regulatory compliance and operational efficiency, operating in complex international environments.The RoleYou will operate with a clear focus on Clinical Safety activities in the pre-marketing (PRE) phase, supporting pharmaceutical and biotech clients during drug development.You 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.As a senior figure, you will also act as Deputy to the Head of Function when required, ensuring continuity of leadership and decision-making.Your ResponsibilitiesAct as senior pharmacovigilance contact and clinical safety lead for assigned client portfolios during the PRE-marketing phaseEnsure oversight of safety surveillance activities within clinical trials, including ongoing vantaggi–risk evaluationGuarantee compliance with global PV and clinical safety regulations (EU GVP, ICH, MHRA, FDA) during drug developmentSupervise preparation and submission of key development safety documents (e.g., DSUR, SUSAR reporting) and support regulatory interactionsLead signal detection and risk assessment activities within clinical