Valeant Pharmaceuticals International
US-CA Senior Drug Safety Specialist 1660-MZ
Senior Drug Safety Specialist Job ID:  1660 Location:  US-CA-Redwood City Category:  Research & Development - Medical Affairs Pos. Type:  Full Time More information about this job:   Overview:     A Drug Safety Specialist 2 is expected to supervise for quality control the work of less experienced staff in the experimental and postmarketing pharmacovigilance areas. That individual shall perform review of safety information on Valeant experimental and marketed drug products to ensure accuracy of MedDRA coding, and as needed, assist in re-coding of legacy cases when upgrading to the most recent MedDRA version. Responsibilities: • Review and interpret all new and follow up reports to determine the appropriate information to enter into the safety database, • Utilize post-marketing/ clinical drug safety concepts to collaborate with relevant internal department (e.g. Medical Affairs, Clinical Affairs, Regulatory Affairs, Biometrics, Project Management, Customer Service, Local Valeant affiliates and manufacturing facilities, etc.) and external partners (Contract Research Organizations, Distributors, other pharmaceutical manufacturers, health care professionals, etc.) to provide appropriate case management and drug safety information for completion of interdepartmental projects. • Identify and evaluate any issues within the department (workflow process, safety database, new regulatory guidances, etc.). Bring all relevant issues to the attention of Pharmacovigilance Management with professional recommendations for improvement. • Generate case narratives, • Collect follow up information if necessary and notify other manufacturers if applicable, • Submit adverse events to appropriate health authorities, affiliates, and country offices, • Maintain and organize all case reports, • Assist Pharmacovigilance Management in the preparation of regulatory reports (e.g. PSURs, IND-Annual Reports, Annual Adverse Drug Reaction Reports, etc.), • Assist Pharmacovigilance Management in conducting drug safety queries requested by health authorities, health care professionals, or internal staff, • Assist in data reconciliation of the AERS database, • Assist Pharmacovigilance Management in supervising temporary or summer intern staff, • Assist Pharmacovigilance Management in other ad hoc tasks and activities as required by management. Qualifications: US citizen and/or green card is required due to access classified information. This candidate must have a bachelor’s degree in nursing, pharmacy or other health care profession and 1-3 years of experience in drug safety or related areas. Advance degree preferred. Candidate must have knowledge of pharmacovigilance requirements in the US and be familiar with requirements of the EU. Candidates must also have excellent communication skills, resourcefulness and personal organizational skills and be committed to working in a fast paced, team-oriented environment. Experience in safety databases, computer software for word processing is required.    Valeant is an equal opportunity employer and supports workforce diversity. . *** Please visit our website at www.valeant.com Forward this job to a Friend! * If a direct employer requests that you go to their web site and complete your application there in order to be   considered, please do so. Applications for all positions are subject to each employer's specific requirements. © Copyright 1994-2009 MedZilla Inc. MedZilla™ is a TRADEMARK owned by MedZilla, Inc.