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PV Coordinator

CRO

South East England

Permanent ⁄ £20000 - £25000

Updated March 7, 2012


The primary responsibility for this position are to:
• Centralise Serious Adverse Event reports received and assigns a unique Serious Adverse Event reference number to the report where delegated.
• Enter Serious Adverse Event information onto the safety database
• Abide by the deadlines for expedited submissions in accordance with individual national authority requirements and ICH E2A
• Obtain information to clarify and support data reported in Serious Adverse Event Forms in an appropriate time frame / obtains medical review of Serious Adverse Events as required.
• Code Serious Adverse Events and the medicines/treatments recorded on the Serious Adverse Event and Adverse Event forms, according to the coding dictionaries in use for the study. Ensure that the safety data set is available for the Sponsor in the timeframe, format and via the method agreed.
• Liaise with Sponsors on expediting Serious Adverse Event reports as required. Generates patient narratives.
• Participates in project teams. Maintains the cumulative Serious Adverse Event section and the pharmacovigilance correspondence section of the Trial Master File (TMF).

Who we're looking for
• Science graduate or equivalent (Ideally in science/ laboratory background).
• Demonstrable Pharmacovigilance experience (spontaneous ADR case management preferred) in a CRO or pharmaceutical environment

• Significant transferable administrative experience

About our client
Medium size CRO

What's on offer
Competitive package.

Michael Page Contact
For further info, apply or phone on 0113 388 9000.  Job Ref: 13222017
Your application will be sent to Emma Whittle.

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Michael Page International plc, Registered in England, Company Number 3310225

Registered Office: Page House, 1 Dashwood Lang Road, Addlestone, Weybridge, Surrey, KT15 2QW