Pharmacovigilance (Pv) Medical Manager

13 ore fa

Firenze, Italia Menarini Group A tempo pieno

Overview:
Main Activities & Responsibilities:

- 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

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