Global Pharmacovigilance

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