Consultant for global Clinical Safety and Pharmacovigilance (m/w/d)

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Marburg |

Freelance

Job title: Consultant for Global Clinical Safety and Pharmacovigilance (m/w/d)

Industry: Pharma

Start of project: ASAP

Duration of the project : 6 months

Capacity: 25-40 hours per week, depending on availability

Location: Remote

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,
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

Qualifications:

Physician
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.

Referenznummer:

Branche:

Beginn des Projekts:

Dauer:

Anstellungsart:

Kontakt

Christina Sons

12021

Pharma

ASAP

6 Monate

Freelance