CPL & TAYLOR by Synergos, ricerca:SENIOR OPERATIONS MANAGER pharmacovigilance– CLINICAL (PRE-MARKETING FOCUS)(Rif. ANN427873)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 Responsibilities
Act 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 benefit–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 programsOversee development and maintenance of Risk Management Plans in alignment with development strategyEnsure robustness of Pharmacovigilance Systems and inspection readiness for clinical programsLead audits, inspections, CAPA management, and remediation activities related to clinical safetyOversee third-party vendors delivering PV and clinical safety servicesProvide technical leadership to PV teams involved in clinical activitiesSupport business development initiatives, proposals, and due diligence activitiesAct as Deputy for the responsible Head, ensuring operational continuity and strategic alignment when required
You may be the right person if
You have at least 5 years of experience in Pharmacovigilance with strong exposure to Clinical Safety (pre-marketing phase)You have solid expertise in ICH guidelines and global PV regulations applicable to drug developmentYou have experience managing DSURs, SUSAR reporting, signal management, and benefit–risk evaluation in clinical trialsYou have experience supporting or leading regulatory inspections and auditsYou have experience overseeing PV systems and vendor managementYou are fluent in English
The Company Offers
Permanent full-time contractGross Annual Salary between €50K and €55K + 10% MBOCorporate welfare package and meal vouchersHybrid working model (2 days per week remote working)
All job postings are open to candidates of all genders (L.903/77).To verify whether the search is still active, please visit https://cpltaylor.it/annunci/#/ and enter the job reference code.Send us your CV even if the selection process is closed: we may contact you for future opportunities.Please read the privacy notice and authorize the processing of personal data in the application form.CPL & Taylor By Synergos SrlRecruitment and Selection – Authorized by MLSPS Prot.13/I/0008775Mantova – Parma – Verona – Modena – Brescia – CremonaMain Office: +39 0376 324703#J-18808-Ljbffr