Job Reference: J5632298
Updated On: 13/02/2020
Status: Now Interviewing
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Role OverviewWe are currently looking for a Head of Pharmacovigilance to join a leading SME Global Biopharmaceutical company based in Hertfordshire area. As the Head of Pharmacovigilance you will be responsible for the Pharmacovigilance department where you will act as UK QPPV.
In this position, you will sit on the Medical Affairs senior management team and will work cross functional with Quality, Regulatory and commercial teams.
This position would suit a Pharmacovigilance expert who is ready to take on a new challenge where they have the opportunity to use their years of experience to streamline internal processes and re-vamp their PV Systems.
Key Duties and ResponsibilitiesYour duties as the Head of Pharmacovigilance will be varied however the key duties and responsibilities are as follows:
1. Act as UK Qualified Person Responsible for Pharmacovigilance ( QPPV ) and be the main point of contact for the MHRA. You will support the EU QPPV to maintain compliance as well as affiliate teams.
2. You will be responsible for the Pharmacovigilance systems including the transition to ArisG. You will maintain compliance with the systems and ensure all staff are trained appropriately.
3. You will be the lead on Pharmacovigilance audits and ensure a high standard of Quality throughout the team.
4. You be accountable for the PV budget and an have oversight of 3rd party vendors.
Role RequirementsTo be successful in your application to this exciting opportunity as the Head of Pharmacovigilance we are looking to identify the following on your profile and past history:
1. Relevant degree in a Life Sciences discipline in addition to extensive Pharmacovigilance experience across case processing, aggregate reporting, signal detection, Risk management plans and PV quality and compliance.
2. Proven industry experience with Pharmacovigilance legislation as well as previous experience of preparing for and leading PV audits.
3. A working knowledge and practical experience of acting as UK/EU QPPV will benefit your application but is not require for the role.
Key Words: Pharmacovigilance | Drug Safety | QPPV | Qualified Person Responsible for Pharmacovigilance | Audits | PV Compliance | Line Management | Continuous Improvement | PV Systems
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