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Medical Review Senior Medical Scientist (MD)
Location:
Thousand Oaks, CA
Description:
Medical Review Senior Medical Scientist (MD) Location: Thousand Oaks, CA /Remote Duration: 23-24 months with possible extension Description: Execute the medical review of ICSRs (narratives, coding, expectedness, causality and seriousness) to ensure quality reports. Produce medically accurate ICSRs reports Act as MSRT product lead and/or therapeutic area lead as assigned Execute ICSR case escalation to GSO as appropriate Execute appropriate case follow up per SOPs Support medical coding conventions, and systematic process improvements for ICSR medical review Maintain list of expected terms in the auto label tool Monitor the compliance of auto label tool updates (if applicable) Support Quality Assurance of ICSR medical review (if applicable) Act as MSRT process lead and support the development, training on and implementation of new processes in MSRT (if applicable) Support training to Client employees on ICSR medical review Mentor junior medical reviewers. Participate in Safety Assessment Team (SAT) Conduct reportability assessment for medical device associated events and/or product complaint associated events, and review for potential product problems. Provide expertise and guidance 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 Perform other duties related to the position as necessary as defined in SOPs 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 Knowledge of Client case management and medical review SOPs and regulatory requirements for Pharmacovigilance Clinical knowledge of therapeutic area patient populations and drug class Proficiency in technical safety systems including the Client Safety database and medical coding Knowledge of safety data capture in clinical trials and in the post marketing environments Knowledge of clinical trials and drug development Knowledge of Client products and patient population Medical Qualification MD/DO or international equivalent plus 3 years relevant work Basic Qualifications Clinical Nursing qualification and 1 year of related drug safety experience Medical Qualification (Nursing Degree); plus 3 years relevant Work Employee Value Proposition : Unique industry opportunity, experience As an equal opportunity employer, ICONMA provides an employment environment that supports and encourages the abilities of all persons without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
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More About this Listing: Medical Review Senior Medical Scientist (MD)
Medical Review Senior Medical Scientist (MD) is a Science & Pharmaceutical Scientist Job at Iconma located in Thousand Oaks CA. Find other listings like Medical Review Senior Medical Scientist (MD) by searching Oodle for Science & Pharmaceutical Scientist Jobs.
Medical Review Senior Medical Scientist (MD) is a Science & Pharmaceutical Scientist Job at Iconma located in Thousand Oaks CA. Find other listings like Medical Review Senior Medical Scientist (MD) by searching Oodle for Science & Pharmaceutical Scientist Jobs.