Remote - Drug Safety Specialist

A highly reputable biopharmaceutical corporation is currently hiring two qualified Drug Safety Specialists to work remotely in the United States.POSITION SUMMARY:The Drug Safety Specialist is primarily responsible for case processing of serious adverse events, serious and non-serious adverse drug reactions and other medically related project information such as adverse events of special interest and product complaints.ESSENTIAL DUTIES AND RESPONSIBILITIES: Reviews, processes, and assesses adverse event reports (AERs) from clinical trials and post-marketing sourcesEnters and maintains safety data in the global safety databasePrepares and submits safety reports to regulatory authorities in accordance with global safety reporting requirementsPerforms QC of cases to ensure quality levels are maintained per company's expectationsManages the safety intake mailbox including the triage of incoming reports for completeness, legibility, and validityQuery managementMaintains electronic documentation for case files within the safety databaseAssists with reconciliation of the safety and clinical trial databasesCollaborates with cross-functional teams to ensure timely and accurate reporting of adverse events to regulatory agenciesAdheres to all relevant pharmacovigilance regulations and company policiesAssists in development of project-specific safety procedures, workflows, and templates.Assists in project-specific safety database setup, management of data entry guidelines, and user acceptance testing.MedDRA and WHODrug coding in the safety databasePreparation for, participation in, and follow-up on audits and inspectionsProvides training and guidance to colleagues on drug safety processes and procedures.Stays updated on industry developments and changes in drug safety regulations.Maintains confidentiality and adheres to ethical standards in handling sensitive and confidential information.Performs other duties and responsibilities as assigned by management.QUALIFICATIONSDegree in Pharmacy, Nursing, Life Science, or other fields, or equivalent qualification/work experienceThe ideal candidate will have 2+ years of recent case processing experience and must include experience processing post-marketing casesMedDRA and WHODrug coding experienceMust be fluent in English with excellent written and verbal communication skillsDetail orientated and capable of working effectively within a team environment.Excellent organizational and prioritization skillsAnalytical and problem-solving skillsAble to perform database/literature searchesExperienced working in RxLogix’s Pharmacovigilance Case Management system a plus