Co-Deputy EU QPPV

Job title : Co-Deputy EU QPPV
Location : Cambridge
Job type : Contract/Freelance
Salary : £450 - £500 per day
Contact name : John Swift
Contact email : john.swift@secpharma.com

I am currently working with one of the worlds leading and most well respected Pharmaceutical companies who are seeking a Deputy EU QPPV for a 3 month contract.

You will be a Delegated co-deputy QPPV accountabilities and responsibilities for specified Medicinal Products Authorised or with a Marketing Authorisation Application (MAA) in the EU:

* Support ensuring the necessary quality, including the correctness and completeness, of Pharmacovigilance (PV) data submitted to the European Medical Agency (EMA), the Pharmacovigilance Risk Assessment Committee (PRAC) and EU national competent authorities.
* Aware of strategic direction for EU Market Authorisation Applications (MAAs) and substantial EU Life Cycle Management (LCM) submissions in relation to own tasks
* Aware of any conditions or obligations adopted as part of EU marketing authorizations and other commitments relating to safety or the safe use of the products in relation to own tasks
* Oversight of the safety profile of Medicinal Products in relation to own tasks
* Oversight of the risk profile of Medicinal Products including associated risk minimisation measures in relation to own tasks
* Review, endorse and sign-off of (EU) Development Safety Update Reports (DSURs), Periodic Benefit Risk Evaluation (PBRERs) and license renewal Addendum to Clinical Overview (ACOs) as assigned
* Review of Post-Authorisation Safety Studies (PASS) protocols for studies conducted in the EU or pursuant to a RMP agreed in the EU, ready for QPPV sign-off. Aware of the results of PASS and provide input to the interpretation of such results.

Please contact me asap on 07392 865 321 or john.swift@secpharma.com for more information.