Medical Review Senior Associate Scientist

<h2><b>Career Category</b></h2>Safety<h2></h2><h2><b>Job Description</b></h2><p>Organization: Global Patient Safety</p><p></p><p>Team: PV Operations</p><p></p><p>Group Purpose: To provide medical review of individual safety case reports (ICSR) in support of safety surveillance for Amgen products. To support global individual case safety reports regulatory reporting compliance.</p><p></p><p>Job Summary:</p><p>•To assure medical validity of ICSRs and provide input to the activities of Medical Safety Review Team (MSRT)</p><p>•Execute the medical review of ICSRs (narratives, coding, expectedness, causality and seriousness) to ensure quality reports.</p><p>•To act as a point of contact for Case Management on medical content of ICSRs</p><p></p><p>Key Activites:</p><p>• Execute the medical review of ICSRs (narratives, coding, expectedness, causality and seriousness) to ensure quality reports. Produce medically accurate ICSRs reports<br />• Execute ICSR case escalation as appropriate<br />• Execute appropriate case follow up per SOPs</p><p>• Support medical coding conventions, and systematic process improvements for ICSR medical review</p><p> • Conduct reportability assessment for medical device associated events and /or product complaint associated events, and review for potential product problems.<br />• Support Quality Assurance of ICSR medical review (if applicable)<br />• Provide input on teams for interdepartmental and cross-functional initiatives including, process improvement, standards development, Standard Operating Procedures (SOP) creation, and metrics with regards to medical review (if applicable)<br />• Perform other duties related to the position as necessary as defined in SOPs or as requested by his/her supervisor<br />Inspection Readiness:<br />• Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness<br />• Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility</p><p></p><p><span>Knowledge and Skills</span> :</p><p>• Knowledge of Amgen Medical review and Case Management SOPs and regulatory requirements for pharmacovigilance<br />• Clinical knowledge of therapeutic area patient populations and drug class<br />• Proficiency in technical safety systems including Safety Database and medical coding<br />• Knowledge of safety data capture in Clinical Trials and Post Marketing setting<br />• Knowledge of clinical trials and drug development<br />• Knowledge of Amgen products and patient population (preferred)</p><p></p><p><span>Education &amp; Experience (Basic):</span></p><p>• MD/DO or international equivalent and 1 year of related drug safety experience</p><p></p><p><span>Education &amp; Experience (Preferred)</span> :</p><p>• MD/DO or international equivalent plus 3 years of relevant work</p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p>.