EU QPPV / Head of Global Drug Safety

Job Title: EU QPPV / Head of Global Drug Safety
Contract Type: Permanent
Location: Rhône-Alpes, France
Salary: bonus, stock options
Start Date: ASAP
Reference: 68793-PHARM-VLB_1497945211
Contact Name: Vladyslav Babych
Contact Email:
Job Published: June 20, 2017 08:53

Job Description

Regular tasks and responsibility:
Primary responsibility for managing and developing the Corporate Drug Safety, Medical Safety Evaluation Group.
Review and coordinate medically appropriate evaluation of Signal management, safety risks and benefit-risk assessments of Medical Safety Evaluation assigned product portfolio in all stages of marketing or development and Europe and international.
Cooperate providing SPC, PBRER, RMP, Development study safety profile,- DSUR, Clinical trials protocols, SAP, Clinical study reports, Clinical overview, PIP, Investigator brochure and ICF.
In cooperation with the QPPV Head responsible for the coordination of Medical Safety Evaluation related medical crisis management;
Coordinate and define Corporate Drug Safety Evaluations Processes;
Manage staff and budget planning of Corporate Drug Safety;

Possibility for career progression is assumed for the right individual

Recruitment for this role is managed by Sr Consultant Vladyslav Babych, for more information and confidential discussion please apply and /or call to Volt Europe office