Job Title: Pharmacovigilance Specialist Pay Rate: $40 / hr Location: Los Angeles, CA Start Date: Right Away Shift: 1st shift Keywords: #PharmacovigilanceSpecialist #Pharmacovigilance #Pharma Benefits: Medical / Health Benefits with multiple plan options, Flexible Spending Accounts, Dental and Vision 401k On the job training / cross-training Life Insurance, disability insurance Voluntary life insurance for family members available Accident and critical illness insurance optional Scheduled performance reviews Referral program Job Description: The Pharmacovigilance Specialist provides operational support for global pharmacovigilance activities of the company's marketed products. Ensures pharmacovigilance deliverables are of the highest quality and meet global regulatory reporting timelines. Responsible for data review, compilation, and analysis, including management of the integrated safety database. Responsibilities: Management of Adverse Events including activities such as processing adverse event case reports and conducting follow-up Notifies regulatory agencies and business partners accordingly Responds to requests from regulatory agencies Reviews scientific literature and bibliographic sources Draft and manage periodic safety update reports Evaluates safety profiles Draft and manage signal detection reports Ensures document filing and archiving Participation in the processes involving the collection, processing, review and distribution of adverse event information regarding development and marketed pharmaceutical products Contributes to ensure compliance of pharmacovigilance activities including activities such as conduct case reconciliation with concerned departments, affiliates, distributors or business partners Take part in self-inspection visits, audits, inspections and in CAPAs management, create or update pharmacovigilance procedures and working practices Provide training to concerned persons based on the training plan and managing training documentation; archive documents according to prevailing standards Support in the procedures of global pharmacovigilance operations such as Standard Operation Procedures (SOPs), internal business practices or working instructions Serves in an advisory capacity including activities such as product monographs review, draft responses to pharmacovigilance requests from regulatory agencies; participates in the drafting and implementation of pharmacovigilance contracts and agreements Requirements: Degree in related field ARGUS database experience preferred PSUR experience preferred If you are interested in this role, please apply via the apply now link provided. Our overriding goal is to provide quality staffing solutions that help people, organizations, and communities succeed. Belcan is a leading provider of qualified personnel to many of the world's most respected enterprises. We offer excellent opportunities for contract, temporary, temp-to-hire, and direct assignments. We are the employer of choice for thousands worldwide. For more information, please visit our website at Belcan.com EOE/F/M/Disability/Veterans #J-18808-Ljbffr Belcan Corporation
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