SENIOR OPERATIONS MANAGER pharmacovigilance – CLINICAL (PRE-MARKETING FOCUS)
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(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:
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 development
You have experience managing DSURs, SUSAR reporting, signal management, and benefit–risk evaluation in clinical trials
You have experience supporting or leading regulatory inspections and audits
You have experience overseeing PV systems and vendor management
You are fluent in English
The Company Offers:
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).
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Recruitment and Selection – Authorized by MLSPS Prot.13/I/0008775
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