SENIOR OPERATIONS MANAGER pharmacovigilance – CLINICAL (PRE-MARKETING FOCUS)

SENIOR OPERATIONS MANAGER pharmacovigilance – CLINICAL (PRE-MARKETING FOCUS) Rif. ANN427873 WORK LOCATION: Rome; 2 days per week of smart working CONTRACT: Permanent contract; full-time SALARY: Gross Annual Salary between €50,000 and €55,000 + 10% MBO + corporate welfare + meal vouchers The Company Our 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 Role You 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 phase Ensure oversight of safety surveillance activities within clinical trials, including ongoing benefit–risk evaluation Guarantee compliance with global PV and clinical safety regulations (EU GVP, ICH, MHRA, FDA) during drug development Supervise preparation and submission of key development safety documents (e.g., DSUR, SUSAR reporting) and support regulatory interactions Lead signal detection and risk assessment activities within clinical programs Oversee development and maintenance of Risk Management Plans in alignment with development strategy Ensure robustness of Pharmacovigilance Systems and inspection readiness for clinical programs Lead audits, inspections, CAPA management, and remediation activities related to clinical safety Oversee third‑party vendors delivering PV and clinical safety services Provide technical leadership to PV teams involved in clinical activities Support business development initiatives, proposals, and due diligence activities Act as Deputy for the responsible Head, ensuring operational continuity and strategic alignment when required

You may be the right person if

Have at least 5 years of experience in Pharmacovigilance with strong exposure to Clinical Safety (pre‑marketing phase) Solid expertise in ICH guidelines and global PV regulations applicable to drug development Experience managing DSURs, SUSAR reporting, signal management, and benefit–risk evaluation in clinical trials Experience supporting or leading regulatory inspections and audits Experience overseeing PV systems and vendor management Fluent in English

The Company Offers

Permanent full‑time contract Gross Annual Salary between €50K and €55K + 10% MBO Corporate welfare package and meal vouchers Hybrid 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 Srl - Recruitment and Selection – Authorized by MLSPS Prot.13/I/0008775 Mantova – Parma – Verona – Modena – Brescia – Cremona Main Office: +39 0376 324703 #J-18808-Ljbffr