Medical Assessor - Global PharmacoVigilance (GPV)

POSITION TITLE: Global PharmacoVigilance (GPV) Medical Assessor

REPORTS TO: GPV Risk Evaluation Unit Manager (and, functionally, to GPV Director / EUQPPV)
BASED: Florence
EXPECTED TRAVEL: Occasional

CONTEXT
The candidate will join the Global PharmacoVigilance (GPV) department within the Risk Evaluation Unit (REU) team. The GPVREU team is in charge of supporting the GPV Director / EU Qualified Person for PharmacoVigilance (EUQPPV) for the activities related to the benefit-risk profile assessment of Menarini medicinal products.

MAIN ACTIVITIES AND RESPONSIBILITIES
In the frame of the GPV Department, being familiar with the EU and non-EU PV legislation and requirements, the ideal candidate will be involved in several activities such as:

• Review of international scientific literature for the assigned medicinal products.
• Signal detection and management for the assigned medicinal products.
• Providing Medical support in writing and reviewing Aggregate Safety Reports such as Periodic Benefit-Risk Evaluation Reports, Development Safety Update Reports, Addendum to Clinical Overview, Risk Management Plans.
• Supporting other Units within GPV (e.g. for Triage and Medical Review of Individual Cases Safety Reports).
• Supporting other Departments (i.e. Regulatory Affairs, Medical Directions, etc.) for preparation of the safety sections of documentation for Marketing Authorisation application or renewal of concerned medicinal products.
• Supporting the GPVREU Manager and GPV Director in ensuring the harmonisation of the SmPC safety sections across the Company territories.
• Supporting the GPVREU Manager and GPV Director in ensuring that any request from the Competent Authorities concerning the benefit/risk profile of a medicinal product is answered fully and promptly.

The mentioned activities require interactions with several internal stakeholders both at Global (Regulatory Affairs, Medical, Marketing, Scientific Service, PV) and Affiliate level (PV), as well as external consultants.

JOB REQUIREMENTS

• Education: Master’s Degree in Medicine and Surgery (mandatory); Specialization, preferably in 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).
• Years of experience: Previous experience in pharmaceutical industry (PharmacoVigilance preferred).
• Qualification and skills: precision, timeliness, good organisation skills, teamwork, knowledge of pertinent medical or pharmaceutical and clinical practice, confidence with electronic tools (MSOffice).
• Language skills and level of proficiency: English intermediate (minimum, as all work documentation and most of the communication shall be carried out in English), good written and verbal communication skills.

Ti senti la persona giusta per questa posizione?
📩 Candidati online nella settimana dal 16 al 22 giugno.