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Job Summary

The position is responsible for performing medical review of Individual Case Safety Reports (ICSRs), conducting medical assessment of all safety related data and ensuring medical accuracy of ICSR narrative, coding and appropriate medical interpretation of all cases. The position is responsible for providing medical oversight and assessment of pharmacovigilance activities as assigned.

Core Responsibilities

? Performs medical review of adverse events reported for both investigational and marketed products
? Maintains familiarity with MedDRA, WHO-DRL and safety databases such as ARGUS.
? Works closely with Safety and Pharmacovigilance (SPVG) colleagues to ensure appropriate medical interpretation and consistency are applied to adverse event case assessment
? Ensures regulatory and SOP compliance with respect to evaluation, reporting and surveillance of clinical and post-marketing safety information
? Identifies, communicates and effectively manages potential safety issues
? Interacts with client’s safety/medical personnel as appropriate
? Stays abreast of clinical and drug development information relevant to contracted programs
? Provides medical review and interpretation for aggregate safety reports (e.g. annual safety reports, PSURs, PADERs)
? Participates in medical safety surveillance/signal detection benefit/risk assessment, and development of trend analyses
? Participates in the development of REMS and RMP as required
? Maintains medical and pharmacovigilance expertise through appropriate internal or external continued medical education (CME)
? Serves as a mentor for other internal safety staff including case processing staff
? Supports business development activities as required
? Responsible for performing activities that are in compliance with applicable Corporate Policies, Standard Operating Procedures, Work Instructions and project specific Operating Guidelines
? Performing other duties as assigned by management.

Qualifications

? Minimum three (3) to five (5) years of experience in the pharmaceutical, biotechnology or device industry working in pharmacovigilance/epidemiology preferred
? Knowledge of global pharmacovigilance regulations and processes
? Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), Visio, email (Outlook), TeamShare (or other management/shared content/workspace), safety databases, and internet. .
? Excellent verbal and written communication skills (proficient in English) as well as in the language required for case processing
? Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to influence
? Ability to travel as necessary (up to 10%)