Specialists in Pharma, Clinical & IT Recruitment

EU-QPPV

Reference:
QPPV
Job Type(s):
PVG / Drug Safety
Salary:
Salary negotiable
Town/City:
London or Paris
Contract Type:
Permanent
Date Posted:
09/10/2013 17:31:00
Start Date:
09/10/2013
End Date:
12/12/2013

Description

My Client is a specialist consultancy within the field of Regulatory Affairs and Drug Safety.

Has opened a new vacancy within the Pharmacovigilance team. They are looking to add a QPPV to be based at either there London or Paris Office

·         Pre- and Post-Market safety cases medical assessment

·         Case narrative review

·         MedDRA coding

·         Interactions with the necessary Regulatory Authorities

·         Risk Management Plans

·         Pharmacovigilance System Master File's preparation

·         Periodic Safety Report review

·         Provide medical expertise on assigned projects where needed

·         Represent the business at relevant conferences within Europe to support business growth

Experience

·         You will need to have experience in Pharmacovigilance at a senior level and also have experience in a QPPV role.

·         Medically qualified Doctor

·         8 years experience within pharmacovigilance working with either a Pharmaceutical, Consultancy or Biotech business

·         Experience in writing RMPs

·         Expert knowledge of EU pharmacovigilance regulations

·         Experience in writing SOPs

·         Knowledge of regulatory requirements in other regulatory regions including the USA or Asia

·         Experience handling inspections and audits

 

More information available on request.

 

For more information regarding this vacancy or a confidential job discussion, please get in touch with Neal Panting. Neal@arc-7.com or +441483 397070

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