Global Safety Manager (Registered Nurse)
Category: Safety
Job ID: R-22556
Location: United Kingdom – Uxbridge
Posted Date: August 1, 2016
Amgen is a leading human therapeutics company in the biotechnology industry. For more than 35 years, the company has tapped the power of scientific discovery and innovation to advance the practice of medicine. As a Fortune 500 company serving millions of patients, Amgen continues to be an entrepreneurial, science-driven enterprise dedicated to helping people fight serious illness.
This Group’s purpose is to provide medical review of individual safety case reports (ICSR) and or ICSRs for products with an established safety profile in support of safety surveillance for Amgen products. To support global individual case safety regulatory reporting compliance
This Medical Review Manager/Global Drug Safety Manager position will assure medical validity and provide input to the activities of Medical Safety Review Team. Execute the medical review of ICSRs (narratives, coding, expectedness, causality and seriousness) to ensure quality reports.
Additional job responsibilities include:
• 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 Amgen 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
Basic Qualifications:
Bachelor’s degree in related discipline and Clinical and/or Drug Safety experience
Preferred Qualifications:
• Nursing degree
• Knowledge of Amgen 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
• Knowledge of Amgen products and patient population
HJE2016
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