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