Overview
The candidate will be part of the Global PV (GPV) Department, in particular, in the GPV IT-LDSU (Team responsible for the management of the PV activities of the Menarini Group Italian LDSUs and Marketing Authorization Holders, MAHs, of medicinal products registered in Italy), interacting with the other Units of the GPV Department as well as other Global and Local Departments.
Main Activities & Responsibilities
The chosen candidate will manage several PV activities such as:
* PV activities for one or more Italian Affiliates (e.g., as a LDSUM / Local Qualified Person for PV (LQPPV) for one or more Italian Affiliate or MAH and Deputy LDSUM/LQPPV for a different Italian Affiliate or a different MAH)
* PV Medical Assessor within GPV Department
* PV activities for the GPV Department
* Cooperation with the GPV Director / European Qualified Person for PV (GPVD/EUQPPV)
* Cooperation with the other LDSUMs and Deputies
* Cooperation with the Local PV Quality Assurance
* Cooperation with the other GPV Units (Safety Operation Unit, SOU; Risk Evaluation Unit, REU; Quality Assurance Unit, QAU; Regulatory Compliance and Training Unit, RCTU)
* Medical Assessment
* Local and International Literature medical evaluation
* Signal Detection activity
* Safety Profile monitoring
* Regulatory enquiries management and medical evaluation of the Product Information
* Safety Information management
* Health Authority safety enquiries management
* Health Authority website monitoring
* Maintenance of the Local PV system, according to the Local and Global procedures of Menarini Group and the Italian and European Regulations and Guidelines
* Management of the Local PV activities and maintenance of the concerning PSMF
* Maintenance of the Local Key Performance Indicators
* ICSR management
* Follow up activities with Health Care Professional (HCP) / Consumer
* Aggregate Reports activity
* PV Agreement activities and management
* Reconciliation with Partners, Providers and other Company Departments
Job Requirements
Degree in Medicine; Specialization, preferably in Pharmacology, Epidemiology, Medical Statistics, Internal Medicine,General Medicine (or equivalent branches, i.e. Cardiology, Neurology, Infectivology, etc.), Hygiene and Preventive Medicine (or equivalent branches).
* Previous work experience: as a physician or at least 1 year in PV, or PV Master
* Knowledge of the main PV requirements and Guidelines (such as GVP)
* Advanced spoken and written of English
* Proactive, flexible as well as excellent analytical and writing skills
* Excellent communication and interpersonal skills
* Strong organizational, planning and problem solving skills
DIGITAL SKILLS:
* Operative System Windows
* Microsoft Office Excel
* Microsoft Office Word
* Microsoft Office Power Point
* Adobe Acrobat Reader
* MedDRA Dictionary