Antal International is a multinational headhunting company with more than 130 offices in 35 countries.

Life Science is a team specialized in talented engineering profiles in production, SCM, R&D, construction, quality, design and technical S&M.

THE COMPANY

Multinational Pharmaceutical Company

THE ROLE

PharmacoVigilance Local Drug Safety Units Manager

The chosen candidate will manage several PharmacoVigilance (PV) activities of the Local Drug Safety Units such as:

• 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
• PV Agreement activities and management
• Health Authority safety enquiries management
• Health Authority website monitoring
• Safety Information management
• ICSR management
• follow up activities with HCP/consumer
• reconciliation with Partners, Providers and other Company Departments
• cooperation with the other Local Drug Safety Unit Managers and Deputies
• cooperation with the Local PV Quality Assurance
• cooperation with the other Units of GPV (GPV Quality Assurance Unit, GPV Risk Evaluation Unit, GPV Drug Safety Unit)
• cooperation with the GPV Director and EUQPPV
• maintenance of the Local KPI
• Regulatory enquiries management and medical evaluation of the Product Information
• Local and International Literature medical evaluation
• Safety Profile monitoring
• Signal Detection activity
• Aggregate Reports activity

PERSONAL ATTRIBUTES

• Degree in Medicine;
• Specialization, preferably in Pharmacovigilance, Pharmacology, Epidemiology, Medical Statistics, Internal Medicine, General Medicine (or equivalent branches, i.e. Cardiology, Neurology, Infectivology, Oncology, 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

Location: Firenze

Please send your CV to - [email protected]

REF: PharmacoVigilance Local Drug Safety Units Manager