Job title: Consultant for Global Clinical Safety and Pharmacovigilance (m/w/d)Industry:
Start of project:
Duration of the project : 6 months
Capacity: 25-40 hours per week, depending on availability
- for marketed products tasks include regular safety surveillance/signaling,
- provision of medical input in periodic safety reports/analyses, risk management plans as needed, chairing the Safety Management team as required,
- Technical advice from the CCDS working team
- responding to requests from the clients regional functions or regulators regarding safety;
- for development compounds, participation in clinical development teams as needed, chairing SMT, defining safety strategy and provision of safety input in clinical dev. documents.
- as required provide safety input in briefing books for discussion with health authorities, input in safety sections of dossiers
- experience as a safety expert in clinical development
- previous significant experience in similar roles (<5 years), i.e. managing and overseeing the safety profiles of marketed products at a global level (signaling, periodic safety report compilation, risk management, authority response to safety questions etc),
- for development compounds defining the safety strategy, risk mitigation, safety input in relevant development documents (IB, ICF, protocol, SAP etc), DSUR compilation, representing safety in clinical development teams
- familiar with Argus database, Empirica.