Drug Safety Specialist

There is a permanent Drug Safety Specialist position available in Costa Mesa, California.

The Drug Safety Specialist will be responsible to perform the initial safety review of post-market adverse events (AEs) and pre-market serious adverse events (SAEs), identify and initiate follow-up through relevant channels, perform the appropriate triage of the reported post-market AEs and pre-market SAEs for regulatory submission as an expedited safety report, generate a cohesive and concise case narrative for the reported events by incorporating relevant information from source documents, and to support open communication of important safety information with the relevant departments . This individual must demonstrate an understanding of safety concepts, ICH and FDA regulations regarding drug safety responsibilities, familiarity with clinical trials, and knowledge of Good Clinical Practices (GCP) of phone, electronic, and fax correspondence regarding initial and case follow-up information. The Drug Safety Specialist will also perform basic safety database searches for data queries and assist various tasks including but not exclusive to SAE reconciliation with the clinical database, PSUR preparation, etc.

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 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:
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.




job Requirements


Please refer to the job description above.