SENIOR PHARMACOVIGILANCE SPECIALIST

Pharma Point Srl; Italia; Remoto; EUR 42.000; Tempo pieno

Descrizione del lavoro

Una consulenza internazionale nel settore farmaceutico è alla ricerca di un Senior Pharmacovigilance Specialist. Sarai responsabile della gestione e del miglioramento del sistema di farmacovigilanza locale, garantendo la conformità alle normative. Si richiedono solide competenze in farmacovigilanza e la capacità di formare giovani colleghi. La posizione è full-remote e offre un contratto permanente con uno stipendio competitivo di €42,000 più vantaggi supplementari.

Servizi

MBO

Tickets Restaurant

Competenze

• Esperienza pluriennale in farmacovigilanza.
• Comprensione della legislazione e delle linee guida di farmacovigilanza.
• Fluenza in inglese e italiano.

Mansioni

• Gestire e migliorare il sistema di farmacovigilanza locale.
• Condurre ricerche bibliografiche locali e gestire ICSR.
• Adattare e inviare PSUR e RMP secondo le normative locali.

Conoscenze

Conoscenze solide in farmacovigilanza

Capacità di formazione e mentoring

Competenze comunicative e di presentazione

Formazione

Laurea in Scienze della Vita

Descrizione del lavoro

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