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Pharmacovigilance, SDEA Manager Salary: On application


Ref: VR/RWIU2

Location: Raleigh / North Carolina, USA

Type: Permanent


A global Pharmaceutical company

We are working with a global Pharmaceutical company in regards to a brand new urgent vacancy within the drug safety department.  This company are well known within the industry for their innovative array of products in multiple therapeutic areas as well as a solid pipeline which is in place for 2019.

 

The PV Department are currently looking for an experienced drug safety professional with a proven background in working with Safety Database Exchange Agreements and Pharmacovigilance Agreements. 

 

This role plays a crucial role within the Patient Safety group and you will be the named contact on all safety agreement matters and will ensure compliance of PV regulations and guidelines on a daily basis.

 

This role will also support all PV Compliance workings and the successful candidate will also be actively involved in audits and inspections. 

 

Responsibilities include:

  • Serving as the SME for all SDEA related issues in-house
  • Managing SDEAs and PV agreements for relevant business partners and stakeholders
  • Working with governance SOPs
  • Ensuring contractual obligations are met in relation to SDEAs

 

Experience required:

  • Strong background in drug safety
  • Excellent understanding of PV agreements / SDEAs
  • Strong understand of PV / Regulatory guidelines
  • Excellent understanding of the drug development process

 

A full briefing is available – please contact Ryan Winter for more details.

 

At RBW Consulting, every one of our consultants has in depth experience in helping Pharmaceutical Professionals find the jobs they are looking for in the industry. With unrivalled industry knowledge and excellent links with hiring managers in Biotechs, Pharmas and CROs throughout the UK, Europe and across the world, we would be delighted to speak with you about the role you are looking for.  Please call the RBW Consulting Switchboard and ask for Ryan Winter – 617 982 1238

 

Salary: On application

Ryan Winter

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