Drug Safety Manager- ICSR

Job Duration:

06+ Months

Job Description Summary:

Responsible for case processing and/or QC of clinical trial ICSRs and post-market case processing from sanctioned countries.

Key Responsibilities:
• Triage, Intake, case entry and QC of ICSRs originating from client sponsored studies or other assigned cases
• Includes narrative writing, MedDRA coding, drafting of follow-up queries and event notifications to internal stakeholders
• Perform retrospective quality checks on processed cases
• Independently manage assigned cases, accounting for weekends and holidays, to deliver cases to internal stakeholders on time and ensure case completion allowing for on-time regulatory reporting
• Review and resolution of reconciliation issues between the clinical and safety databases per in collaboration with Data Management
• Provide investigation details into late regulatory reporting of CT cases

Essential Skills and Qualifications Required:
• Knowledge of Global and local safety regulations
• Excellent written and verbal communication skills
• Experience in ICSR processing in safety database systems such as ArisG, Argus and Veeva
• Understanding of global safety reporting regulations and guidelines including the FDA, ICH, and EU Regulations and Requirements for Pharmacovigilance
• Strong computer skills within Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook)
• Knowledge of medical and clinical practices and a strong understanding of medical concepts and terminology required

Education and Experience Requirements for Job:
• Education : Bachelor’s degree in science or healthcare related field
• Experience : 4+ years experience in pharmacovigilance