QPPV office manager

BioTalent is representing an established European based BioTech with support required as an QPPV Office Manager for either as a permanent employee or on a long term contract (12-24 month period). You will report into the EU QPPV. The role is remote with optional/occasional/monthly visit to EU Headquarters

Responsibilities:

Be the main point of contact to EU and local PV colleagues (global responsibility too)

Experience:

• GVP/Global Patient Safety (updates, planning and implementation), support documents (SOPs PSMF RMP, PSUR, PV Agreement, Safety detection), Cross functional working, support during audit and inspection, knowledge of EU and Global regulatory legislation requirements/submissions related to safety
• Minimum 3 years industry experience in PV
• Experience as a local safety person is desirable

If this role is for you then please be in contact with dominic.pritchard@biotalent.com