Global PharmacoVigilance (GPV) Medical/Scientific Assessor
Join to apply for the Global PharmacoVigilance (GPV) Medical/Scientific Assessor role at MENARINI 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 benefit-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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