Join to apply for the Medical Safety Reviewer role at Planet Pharma 1 day ago Be among the first 25 applicants Join to apply for the Medical Safety Reviewer role at Planet Pharma 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 as assigned Execute ICSR case escalation 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 Support Quality Assurance of ICSR medical review Participate in Safety Assessment Team (SAT) (if applicable) Conduct reportability assessment for medical device associated events and /or product complaint associated events, and review for potential product problems Provide input on teams for interdepartmental and cross-functional initiatives (if applicable) Perform other duties related to the position as necessary as defined in SOPs or as requested by his/her supervisor Job Description Pay rate: 54-64/hr depending on range Medical Review Scientist (nurse) 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 as assigned Execute ICSR case escalation 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 Support Quality Assurance of ICSR medical review Participate in Safety Assessment Team (SAT) (if applicable) Conduct reportability assessment for medical device associated events and /or product complaint associated events, and review for potential product problems Provide input on teams for interdepartmental and cross-functional initiatives (if applicable) 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 And Skills Knowledge of 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 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 products and patient population (preferred) Qualifications Clinical Nursing qualification and 3 years of related drug safety experience Medical Qualification (Nursing Degree); plus 5 years relevant work The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Seniority level Seniority level Not Applicable Employment type Employment type Full-time Job function Job function Administrative Industries Staffing and Recruiting Referrals increase your chances of interviewing at Planet Pharma by 2x Sign in to set job alerts for “Reviewer” roles. T&S (Trust & Safety) Policy Writer & Research Specialist Thousand Oaks, CA $26.00-$29.00 3 days ago Senior Staff Writer, MD+DI (Open to Any US Office) Westlake Village, CA $144,000.00-$216,000.00 1 day ago Resource Family Home Study Writer Bilingual Preferred Whole Body Order Writer (Body Care, Makeup, Vitamins, Nutrition - Buyer / Inventory Replenishment) - Part Time Specialty Order Writer (Beer, Wine, Cheese & Chocolate Buyer / Inventory Replenishment) - Full Time Thousand Oaks, CA $17.50-$30.20 1 week ago Whole Body Order Writer (Body Care, Makeup, Vitamins, Nutrition - Buyer / Inventory Replenishment) - Full Time Services Trainer & Technical Writer - Data Center Solutions Senior Manager, Business Development Proposal Writer Westlake Village, CA $100,000.00-$140,000.00 2 weeks ago Full Time Nabisco Merchandiser/Order Writer We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr Planet Pharma
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