SENIOR OPERATIONS MANAGER pharmacovigilance – CLINICAL (PRE-MARKETING FOCUS)
(Rif. ANN427873)
WORK LOCATION: Rome; 2 days per week of lavoro da remoto
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
Overs