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[New Job Opening] Drug Safety Associate II ( 2 open positions ) San Carlos or Remote job Vacancy in San Carlos, CA 94070

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Job Details:
Position Name :
Drug Safety Associate II ( 2 open positions ) San Carlos or Remote
Location:
San Carlos, CA 94070
Job ID :
1cf8e1d0d31abf87
Description : OverviewThe Drug Safety Associate II candidate works in a team-oriented, dynamic, and collaborative environment. This person would manage the drug safety mailbox, track case workflow, support the drug safety activities while adhering to all data privacy guidelines, Good Clinical Practices (GCPs), Good Pharmacovigilance Practice (GVP), regulatory guidelines, company and project/program-specific procedures. Ensures compliance with standard operating procedures, regulatory, safety and pharmacovigilance in compliance with national and international regulations, such as the Food and Drug Administration (FDA), World Health Organization, country, and regional regulations for the reporting of adverse events to regulatory agencies.Specific Responsibilities: Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Demonstrates good judgment in selecting methods and techniques for obtaining solutions. Networks with senior internal and external personnel in own area of expertise.Supports all clinical safety (CS) and pharmacovigilance (PV) aspects of Iovance clinical studies and post market productsMonitor and manage safety inbox including archiving of emails and documentsUpdate and manage various Workflow as well as submission trackersReview triage assessments and monitor the incoming reportsPerforms case management including receipt, duplicate check, book-in, assessment of seriousness and expectedness, data entry and narrative writingInterpret case-related information including medical conditions, lab results and procedures, as well as compile complete narrative summariesReview data to ensure case accuracy with minimal error in narrativesReview MedDRA and WHODrug coding as neededReview, enter, and verify follow-up information for cases and make accurate determination of significant informationPerform review of ancillary documentation accompanying ICSR reports and identify pertinent information for incorporations into the case narrativeCorrectly identify cases requiring targeted follow-up, and determine relevant follow-up queriesMeet specific data and quality targets for case handlingLiaise with safety physicians, medical monitors, sites, clinical department, affiliate, vendor, or other organizations as needed on safety data issuesRecognize situations that require assistance from more senior staff members or Safety Physicians and seek assistance from appropriate internal resourcesDemonstrates general understanding of appropriate labeling documents for study productsOrganizes workload to ensure departmental workflow processes and timelines are followedMay assist manager with other projects including but not limited to the preparation of training materials, global PV system compliance and vendor management activitiesMay support PV Audit and Inspection preparationMay participate in other activities, as needed or as requested by the supervisorRemain current with Iovance SOPs, guidance documents and database technologyMay perform Quality Control on other team member’s workAble to work independently and prioritize workloadOther duties as assignedEducation and Qualifications: Healthcare professional degree (i.e., RN, PharmD) with minimum of 1year professional experience or Bachelors’ degree in life sciences or equivalent relevant scientific qualifications with minimum of 3 years of experience in drug safetyKnowledge of global safety regulations, ICH Guidelines, and other applicable regulatory guidance documentsExcellent interpersonal and communication skills, both written and oralExcellent computer skills in Microsoft environment (Microsoft Excel, Power point and Word).Safety database and case processing experience preferredOncology experience or knowledge preferredAbility to assess data and understand the medical/safety implicationsDemonstrates initiative, teamwork and accountabilityDemonstrated success working both independently and in collaboration with othersA quality driven individual with strong attention to detail and accuracy is requiredStrong organizational skills, and ability to adapt to changeAbility to follow guidelines and procedural documentsSelf-motivated and capable of working independentlyUnderstands safety database structures and is familiar with data retrieval tools is preferredIovance collects, uses, and discloses your personal information in accordance with its Candidate Privacy Notice.Job Type: Full-time
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