Associate Director, Global Pharmacovigilance Operations

Responsbilities:

Provide Pharmacovigilance operational expertise and support for assigned pipeline and marketed products in an assigned therapeutic area.

Represent Safety group internally/externally at a global level

Case review/Case report QC

Supports aggregate safety reports (PSURs DSURs) and RMPs

Supports developmental activities, including marketing applications

Involvement in SDEA/PV agreements as needed at a Global and Local level

Involvement in design of protocols, Investigator Brochures, SAPs, CSRs and other relevant project documents.

Requirements:

2+ years in a US or Global Pharmacovigilance function

Strong PV database experience ideally including ARGUS

Good Clinical Trial understanding and real world experience, combined with strong regulatory knowledge

Excellent written and verbal communication

The successful candidate will be based in Cambridge, Massachusetts full time and will have full right to work in the US.

For full details please apply directly or send your resume to Jon.Phillips@Pharma-Partners.net

Pharma-Partners is a leading provider of world-class talent acquisition solutions to the Life Science industry across the United States and Europe with offices in Boston, Mass. and Reading, U.K, specialising in Physicians within Pharmacovigilance, Medical Affairs and Clinical Development. For further information please visit www.Pharma-Partners.co.uk