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Drug Safety Physician Ref: 24388

Salary:£500 - £700 per day

Added:10 Jul 2019

Region: London

Sector: Pharmaceutical

Sub Sector: Drug Safety

I am currently recruiting for an interim PV Physician to join a client on an initial 3 month contract basis. Within this role you will execute and manage Pharmacovigilance projects global clients. This role is 100% home based! Responsibilities: *Author Risk Management Plans (RMP) and review of RMP updates *Medical Review of PSURs/PBRERs per the Regulations and SOPs. *Authoring Benefit Risk sections of aggregate reports *Review of Literature reports for ICSR identification and signal detection *Medical Review of ICSRs for purpose of expedited/ periodic reporting for client's products including MedDRA coding, labelling assessment and causality assessment. *Preparation of responses for queries to be submitted to regulatory authorities. *Contributing as part of the Medical review team to develop processes, training plans/modules and SOPs. Experience: *An EU medical degree. *Strong post-marketing pharmacovigilance experience to include risk management, signal detection, aggregate report writing and medical review experience, either in a pharmaceutical company or with a CRO is required. *Experience in writing risk management plans, benefit risk assessments and signal detection is essential. *Experience of Medical Review of Literature reports for ICSR and signal detection purposes is highly desirable. *Experience of medical review of ICSRs for purposes of expedited/ periodic reporting for client's products including MedDRA coding, labelling assessment and causality assessment is desirable. *Good understanding of clinical development processes including principles of clinical study operations, and ICH-GCP guidelines. *Team management and project management experience. For further details, please contact Ross Wilson on +44(0)1727 817 621 or email a copy of your CV to rwilson@keypeople.co.uk

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