Pharma Point, on behalf of a leading international consultancy company operating in the pharmaceutical sector, is seeking an experienced Senior Pharmacovigilance Specialist to be based in Italy.
The selected professional will be responsible for the management and continuous improvement of the local pharmacovigilance system, ensuring compliance with both local and global requirements and maintaining close collaboration with cross-functional and global teams.
Main Responsibilities:
* Establish and manage the local pharmacovigilance (PV) system
* Conduct local literature searches, ICSR management, and PV intelligence screening
* Maintain local PSMF and manage local Organized Data Collection activities
* Manage local Pharmacovigilance Agreements (PVAs)
* Adapt and submit PSURs and RMPs in accordance with local regulatory requirements
* Perform signal detection and implement additional risk minimization measures
* Review materials related to local post-authorization safety activities
* Participate in PV-related audits and inspections
* Provide monthly PV reports on the status of the local PV system
* Ensure PV training for affiliates, service providers, and third parties
* Cooperate closely with global PV systems and relevant departments
* Review, issue, and maintain local pharmacovigilance SOPs and working practices
* Act as main contact for the Deputy PV activities and ensure adequate delegation during absences
Requirements:
* University degree in Life Sciences (preferred)
* Several years of experience and solid knowledge in pharmacovigilance
* Strong understanding of pharmacovigilance legislation and guidelines
* Proven ability to lead, mentor, and train junior colleagues
* Strong communication and presentation skills, with the ability to manage both internal and external relationships effectively
* Business fluency in English and Italian
Location: Full-remote
Employment Type: Permanent position
Offer: CCNL Chimico-Farmaceutico, Livello B, RAL €42,000 + MBO + Tickets Restaurant