Overview: - REPORTS TO: GPV Risk Evaluation Unit Manager (and, functionally, to GPV Director / EUQPPV)- EXPECTED TRAVEL: OccasionalMain Activities & Responsibilities: - Review of international scientific literature for the assigned medicinal products. - Signal detection and management for the assigned medicinal products. - Providing 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. - Supporting other Units within GPV (e.g. for Triage and Medical Review of Individual Cases Safety Reports). - 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: - Master’s Degree in Medicine and Surgery (or Pharmacy complemented by Master's Degree in Pharmacovigilance and >10 years of experience in similar PV role) - Previous experience in PharmacoVigilance (>10 years if not Medical Doctor) - Precision, timeliness, good organisation skills, teamwork, knowledge of pertinent medical or pharmaceutical and clinical practice, confidence with electronic tools (MSOffice) - English intermediate (minimum, as all work documentation and most of the communication shall be carried out in English), good written and verbal communication skills