Beschreibung
Are you currently looking for a new and exciting freelance project?Our client, an innovative biotech company, is looking for a freelancer for Global Clinical Safety and Pharmacovigilance.
Project Tasks:
- 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
- Responding to requests from companies 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
Your Experiences:
- Physician; 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
- English, German is a plus
Further Details:
- Project start asap; for about 6 months
- 40 working hours per week
- Remote; company is in Marburg
If you are interested, please do not hesitate to contact me at your earliest convenience at m.schaeffer[a]progressive.de
P.S.: If you do not have free capacities and/or this is not in line with your current career endeavor, I invite you to forward this opportunity within your network.
Kind regards,
Monika Schäffer
Candidate Consultant
Life Sciences - Pharma & Biotech