Jim Gleeson at CK Clinical is currently recruiting for an Associate Director of Clinical and Pharmacovigilance QA to join a global pharmaceutical company at their EU Headquarters based in London.
As Associate Director of Clinical and Pharmacovigilance QA, you will provide overall leadership for all EU QA activities within Clinical Development and Pharmacovigilance. In liaison with the global QA team your remit will be to ensure that these activities are fully compliant with ICH-GCP regulations and company policies and procedures.
Further responsibilities will include:
- Act as the key QA representative for competent authority inspections for clinical trials and pharmacovigilance
- Ensure that investigator, vendor, facility and system audits are carried out, that critical compliance risks are communicated to senior management and the corrective actions are implemented
- Provide EU regional input to global quality initiatives
- Identify and mitigate quality and compliance risks
- Manage the EU aspects of the clinical audit and corrective action tracking database
The ideal candidate:
To be considered for this Associate Director of Clinical and Pharmacovigilance QA Job in London you will have the following skills, qualifications and experience:
- Extensive and broad QA experience gained as either a client or vendor
- Experience of study design, set up and conduct as well as of audits of all types
- In depth knowledge of GxP regulations, EU regulations, FDA Good Clinical Practice and ICH guidelines
- An understanding of Computer System Validation
- Proven line management skills
How to apply:
For more information, or to apply for this Associate Director of Clinical and Pharmacovigilance QA please contact Jim Gleeson at CK Clinical on 01438 870027 or email firstname.lastname@example.org. Please quote reference CL23220 in all correspondence.