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Job Details

PW 6645 Global Safety Manager

Company: AXESS
Location: Greater London
Reference: PW 6645
Closing Date: 19 Feb 17
Type: Permanent
Salary (£): Competitive
Benefits: Comprehensive befits package including stock options

Job Summary:

This leading biopharma company requires a Global Safety Manger who will assure medical validity and provide input to the activities of Medical Safety Review Team. Execute the medical /scientific review of ICSRs (narratives, coding, expectedness, causality and seriousness) to ensure quality reports. This role will have a European focus and sit within a growing global team.



Leading global biopharma company

Growing safety team



·         Execute the medical review of ICSRs (narratives, coding, expectedness, causality and seriousness) to ensure quality reports. Produce medically accurate ICSRs reports

·         Execute medical triage for appropriate causality assessment on ICSRs and timely regulatory reporting Execute ICSR case escalation to Senior Medical Reviewer as appropriate

·         Execute appropriate case follow up per SOPs

·         Support medical coding conventions, data collection methods, and systematic process improvements for AE processing

·         Support training to company employees on ICSR medical review.

·         Participate in SAT as requested

·         Provide expertise and guidance on teams for interdepartmental and cross-functional initiatives including, process improvement standards development, SOP/MAN creation, and metrics with regards to medical review and case management

·         Perform other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by his/her supervisor

Inspection Readiness

·         Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness

·         Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility



·         Bachelor’s degree in related discipline and Clinical and/or Drug Safety experience

·         Preferred Qualification: Nursing degree

·         Knowledge of Case Management and medical review SOPs and pharmacovigilance regulatory requirements for pharmacovigilance

·         Clinical knowledge of therapeutic area patient populations and drug class

·         Proficiency in technical safety systems including Safety Database and medical coding

·         Knowledge of safety data capture in Clinical Trials and Post Marketing setting

·         Knowledge of clinical trials and drug development

Before you apply for this position it is vital that you are in possession of an EU or UK passport or relevant visa to work without restrictions in the UK.



For a confidential discussion please telephone Christian Simon at AXESS Limited on 020 8560 2300. To apply, please send your CV to quoting reference PW 6645



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AXESS has been operating since 1990

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Apply for this job:  PW 6645 Global Safety Manager

Contact Information:

Address:  Head Office
Isabella House,
12 Union Court,
Richmond upon Thames,
Tel:  +44 (0)20 8560 2300
Fax:  +44 (0)20 8560 2033
Website:  Visit Our Web Site

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