QPPV - Pharmacovigilance Manager
I am currently recruiting for a client of mine based in the North West on a CONTRACT basis for a QPPV - Pharmacovigilance Manager.
The position will be responsible for establishing and maintaining the Market Authorisation Holder's Pharmacovigilance System - overseeing all safety profiles of the companies marketed products in the EU.
At present the Pharmacovigilance activities are contracted out to a service provider so the role will initially involve the setting up of the in house PV system and team. They will then be responsible for handling the transfer of material from the contractor to the in house system.
Having an oversight of the PV system and delegates tasks and maintaining ultimate responsibility on them, including:
- Oversight on Individual case safety reports (ICSRs),
- Standards Operating Procedures (SOPs),
- Periodic Safety Update Reports (PSURs),
- Risk Management Plans (RMP),
- Risk Minimisation Strategies, effectiveness of follow-up measures, of post-marketing commitments, on safety database, on e-transmission and on important observations from QA audits of PV activities
Keep up to date about the relevant regulations, legislation and literature of Pharmacovigilance, pharmacology and pharmacoepidemiology
Ensure full compliance of the MAH's PV system with the European regulations
Lead the preparation of aggregate safety reports (PSURs, DSURs, RMPs, safety issue workups etc), thus contributing to high quality standard documents within the organization
Strong experience in pharmacovigilance (8+ years) in Pharmaceutical Companies, Biotech or CRO
Excellent knowledge of EU pharmacovigilance regulation and legislation
Medically qualified Doctor preferred but not essential
Strong expertise in medical safety writing
Experience in writing SOPs
Contract Length: 12 Months
Location: North West
Start Date: ASAP
If this role is of interest to you then please send an updated version of your CV and i will be in touch.
Alternatively if you know anyone who maybe interested then please pass this on.
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