Global PharmacoVigilance (GPV) Medical/Scientific Assessor
Join to apply for theGlobal PharmacoVigilance (GPV) Medical/Scientific Assessorrole atMENARINI Group.
Overview
The candidate will join the Global PharmacoVigilance (GPV) department within the Risk Evaluation Unit (REU) team.
The GPVREU team supports the GPV Director / EU Qualified Person for PharmacoVigilance (EUQPPV) in activities related to the vantaggi-risk profile assessment of Menarini medicinal products.
Reports to: GPV Risk Evaluation Unit Manager and (functionally) to GPV Director / EUQPPV.
Occasional travel expected.
Main Activities & Responsibilities
Review of international scientific literature for the assigned medicinal products.
Signal detection and management for the assigned medicinal products.
Provide scientific 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.
Support other units within GPV (e.g., Triage and Medical Review of Individual Cases Safety Reports).
Support other departments (e.g., Regulatory Affairs, Medical Directions) in preparing safety sections of documentation for Marketing Authorisation application or renewal of concerned medicinal products.
Support the GPVREU Manager and GPV Director in ensuring the harmonisation of the SmPC safety sections across the Company territories.
Support 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.
Job Requirements
Master's Degree in Medicine and Surgery (or Pharmacy complemented by a Master's Degree in Pharmacovigilance) and >10 years of experience in a similar PV role.
Previous experience in PharmacoVigilance (>10 years if not a Medical Doctor).
Precision, timeliness, good organisational skills, teamwork, knowledge of pertinent medical or pharmaceutical and clinical practice, confidence with electronic tools (MS Office).
Intermediate English (minimum; all work documentation and most communication will be in English); good written and verbal communication skills.
Seniority Level
Mid-Senior level
Employment Type
Full-time
Job Function
Management and Manufacturing
Industries
Pharmaceutical Manufacturing
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