|Job title :||Associate Director - GVP QA|
|Job type :||Permanent|
|Contact name :||John Spring|
|Contact number :||+44 (0) 207 255 6650|
|Contact email :||email@example.com|
This position is a great opportunity for an experienced PVQA professional looking to advance their career with a fast growing biopharmaceutical company at the forefront of biomedical technology. This position will be based either in the US or Germany and requires someone who is highly experienced in GVP QA and PV to help the company achieve their goals in 2021 and beyond. The role can be based either in the US or in Germany.
Salary & Benefits:
Excellent salary and benefits. Full details on request.
Role and responsibilities:
*Plan, perform and follow-up pharmacovigilance (PV) and Drug Safety (DS) audits of internal PV/DS systems and processes of the company's HQ and subsidiaries as well as external vendors and service providers.
*Coordinate and supervise PV audits with external auditor
*Host and follow-up of authority inspections, especially in PV / safety topics
*Write and review QA SOPs and PV SOPs
*Provide expert advice in Good Pharmacovigilance Practice (GVP) procedures within relevant departments (e.g. Drug Safety & Pharmacovigilance, Medical Affairs, Clinical Operations, Clinical Development, Regulatory Affairs)
*Ensure continuous improvement of the internal QMS with particular attention to the generation and update of the PV auditing strategy as well as the establishment of PV quality metrics
*Provide GVP support and training to other departments involved in clinical trials and drug safety / PV activities
*Establish and maintain a database of references (regulations, standards, guidelines) applicable to drug safety / PV topics
Requires skills and qualifications:
*Life Sciences Degree with a minimum of 5 years of professional experience in GVP Quality Assurance within pharmaceutical and/ or biotech industry
*Experience in hosting and following-up of authority inspections including pre-approval inspections
*Sound knowledge in international regulations and guidelines (EU / FDA regulations, ICH, etc.)
*Fluent in English
To apply for this position and put yourself under immediate consideration, send your CV to firstname.lastname@example.org or call +44 (0) 207 255 6650