Diabetes Global Safety Physician (H/F)
The Global Safety team is strongly international and works in a transversal manner. Within the PV Global Department (with more than 50 global safety physicians) Diabetes is one of the strategic therapeutic areas. Poste Reporting to the Global PV Therapeutic Area Head (located in Germany), you provide medical input on the safety evaluation of established drugs and drugs under development in diabetes area and work closely with your team (internal and vendors GSP).Thus you:- Provide PV and risk management expertise to internal and external customers as a safety expert,- Lead aggregate safety data review activities and coordinate safety surveillance activities,- Maintain knowledge of product, product environment, recent literature and understanding of international safety regulation and guidelines,- Communicate with and represent PV position within project/product teams, with external partners, key opinion leaders, and Health Authorities, and during internal and external negotiations,- Responsible for signal detection and analysis, you collaborate with Center of Excellence for Signal Detection and Data Mining and Safety Epidemiology group,- Provide proactive risk assessment and develop risk management strategies,- Represent safety position in cross functional submission teams,- Document, coordinate, review and validate Periodic reports.
Profil A qualified Doctor of Medicine (MD), you have a 5-year proven and successful track record in global pharmacovigilance position in the pharma industry. Your clinical experience will also be considered.At ease to combine and critically analyse data from multiple sources (aggregate data, not only single case review) you know how to develop and document risk assessment.Your excellent clinical judgement helps you to communicate about complex clinical issues and analysis, both orally and in writing.An excellent teamworker with outstanding interpersonal skills, you demonstrate leadership within a cross-functional team environment.Fluent English essential.