We have an exciting opportunity available as a Pharmacovigilance Compliance Manager working at a growing Pharmaceutical Company. This is a fantastic opportunity for an experienced Pharmacovigilance Manager to enter into a senior position with increasingly Quality Assurance responsibilities.
Manage GDS compliance including monitoring the Quality Incident Tracker.
Performing QA review on procedures and working instructions.
Co-host audits of the Global PV system.
Update and maintain quality incident tracking systems and QA documentations
Perform gap analysis as part of inspection preparation or audit of PV system and collaborate with stakeholders to resolve deficiencies prior to inspection
Many more to be discussed after application!
Life science degree or quality background
Pharmacovigilance experience in industry, with experience in successful European and/or FDA Pharmacovigilance inspections
Experience with compliance and/or quality systems management. Developing SOPs, PV audits, CAPAs and training in PV organisations.
Knowledge of global PV regulations, EMA, FDA and ICH
This opportunity has understandably been incredibly popular. We encourage all interested candidates to apply without delay as it is likely that recruitment will close prematurely. Please direct all questions (if necessary) to “Simon” at firstname.lastname@example.org alongside a copy of your CV.