Pharmacovigilance Compliance Manager - Exciting Pipeline

Barrington James Ltd
13 Nov 2017
16 Nov 2017
Contract Type
Full Time
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.

Responsibility Summary

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!

Experience Requirements

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

A very competitive starting salary - outstanding benefits including Holiday, Healthcare, Pension and Bonus

Please direct all questions (if necessary) to "Chris" at ************************** cswain (at) barringtonjames (dot) com alongside a copy of your CV.