Senior REMS Expert

2 weeks ago


Leigh, Wigan, United Kingdom Intone Networks Inc Full time

Hi All

We are seeking a highly experienced Senior REMS Expert to join our team at Intone Networks Inc.

Role : Senior REMS Expert

Location : Remote (Hybrid)

Hire Type : Contract

Indent : PSL

Year of exp : 12

Job Description :

Around 12 Years experience in healthcare domain

Should have sound experience in Risk Evaluation and Mitigation Strategy (REMS).

Hands-on experience in Periodic review reports RMM tracking with REMS support as per the Regulations and Standards Operating Procedures (SOPs)

A deep knowledge of Drug safety FDA REMS program requirements and key processes.

Experience in design and implementation of REMS systems and tools.

Good understanding of SDLC requirements and 21 CFR Part 11 GxP guidelines

Prior experience of participating in designing and implementing REMS systems

Experience of implementing or using CRM systems such as Salesforce Dynamics (highly advantageous)


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