Job Title

Snr Clin Compliance Specialist, Auditing

Salary

£46,000 - £59,999

Job Type

QA GCP/PVG, GCP/PVG Inspections

Location

Switzerland

Employment Type

Permanent Job

Employer Type

PM Pharmaceutical R&D HQ (Global Or EU)

Seniority

Senior Executive/Team Leader

Duration

 

FTE Hours

Full Time 35 - 40hrs Per Wk

Vacancy Status

Open For Applications

Date Posted

Wed 8th Oct 2008, 12:59pm

Introduction
Our Client, a top 5 Pharma company, seeks a permanent Clinical Compliance Specialist, with responsibility for auditing.

Summary of duties
Conduct of audits, internally and externally, e.g. Clinical Investigator Sites, CROs/Licensing^Candidates, Laboratories, pharmacovigilance and clinical development systems at headquarter as well as at local level.
Providing project information to support audit schedule generation, audit preparation and conduct.
Interprets GCP regulations,^guidelines, policies and procedures.
Researching local and international initiatives, trends and events in order to maintain compliance.
Review and advice on guidelines, policies and company SOPs.
Coordination of inspectional activities, including investigator, sponsor/monitor/CRO, and IRB/EC inspections both locally and abroad.
Providing guidance to company personnel and contracted service providers, both verbal and written.
Interaction and education of internal functions, as well as clinical site personnel, CRO/vendor, personnel, etc on various aspects of compliance.
Representation of CQA in internal and external meetings, networks with external bodies e.g. European Forum for GCP

Qualifications required
Biomedical Science degree (master) or equivalent
Demonstrated previous auditing experience in more than one country, or demonstrated clinical research management experience in Phase II-III
English (optimally a second universal language)
Willingness to travel up^to 40%
Proficiency with basic computer skills
Excellent verbal and written communication skills
Expert in pharmacovigilance and GCP/ICH regulations
Ability to multi-task and function independently as required
Auditor certification (desirable)