PharmacoVigilance (PV) Medical Manager

Menarini Group; Firenze; In loco; EUR 40.000 - 60.000; Tempo pieno

Descrizione del lavoro

A leading pharmaceutical company in Florence is seeking a candidate to join their Global PV Department. The role involves managing pharmacovigilance activities for Italian affiliates, conducting medical assessments, and collaborating with various departments. Ideal candidates will have a degree in Medicine, experience in PV, and strong communication skills. This position offers opportunities to engage with multiple teams and contribute significantly to patient safety management.

Competenze

• Degree in Medicine, preferably in Pharmacology or related fields.
• Previous experience as a physician or at least 1 year in pharmacovigilance.
• Knowledge of main PV regulations and guidelines.
• Advanced proficiency in spoken and written English.
• Proactive and flexible approach.

Mansioni

• Manage PV activities for Italian Affiliates.
• Perform Medical Assessments within the GPV Department.
• Collaborate with GPV Director and other units.
• Conduct literature medical evaluations and signal detection.
• Prepare aggregate reports and manage safety information.

Conoscenze

Analytical skills

Communication skills

Problem-solving skills

Interpersonal skills

Writing skills

Formazione

Degree in Medicine

Strumenti

Microsoft Office

Windows Operating System

Adobe Acrobat Reader

MedDRA Dictionary

Descrizione del lavoro

Overview

The candidate will be part of the Global PV (GPV) Department, specifically within the GPV IT-LDSU team responsible for managing PV activities for the Menarini Group's Italian LDSUs and Marketing Authorization Holders (MAHs) of medicinal products registered in Italy. The role involves interaction with other units within the GPV Department as well as global and local departments.

Main Activities & Responsibilities

The selected candidate will handle various PV activities, including:

• Managing PV activities for one or more Italian Affiliates, such as LDSUM / Local Qualified Person for PV (LQPPV) for specific affiliates or MAHs, and Deputy LDSUM/LQPPV for others
• Performing PV Medical Assessments within the GPV Department
• Supporting PV activities across the GPV Department
• Collaborating with the GPV Director / European Qualified Person for PV (GPVD/EUQPPV)
• Cooperating with other LDSUMs and Deputies
• Working with Local PV Quality Assurance
• Engaging with other GPV Units (Safety Operation Unit, SOU; Risk Evaluation Unit, REU; Quality Assurance Unit, QAU; Regulatory Compliance and Training Unit, RCTU)
• Conducting Medical Assessments
• Performing local and international literature medical evaluations
• Participating in signal detection activities
• Monitoring safety profiles
• Managing regulatory enquiries and medical evaluations of product information
• Handling safety information management
• Managing health authority safety enquiries
• Monitoring health authority websites
• Maintaining the Local PV system according to Menarini Group procedures and relevant regulations
• Managing Local PV activities and maintaining the PSMF
• Monitoring Local Key Performance Indicators
• Managing ICSR activities
• Following up with healthcare professionals and consumers
• Preparing aggregate reports
• Managing PV agreements and related activities
• Reconciliation with partners, providers, and other departments

Job Requirements

Degree in Medicine, preferably with specialization in Pharmacology, Epidemiology, Medical Statistics, Internal Medicine, or related fields such as Cardiology, Neurology, Infectious Diseases, Hygiene, and Preventive Medicine.

• Previous experience as a physician or at least 1 year in PV or PV Master
• Knowledge of main PV regulations and guidelines (e.g., GVP)
• Advanced proficiency in spoken and written English
• Proactive, flexible, with excellent analytical and writing skills
• Excellent communication and interpersonal skills
• Strong organizational, planning, and problem-solving skills

DIGITAL SKILLS:

• Windows Operating System
• Microsoft Office (Excel, Word, PowerPoint)
• Adobe Acrobat Reader
• MedDRA Dictionary