Planet Pharma
From Planet Pharma's careers page
Status: listed on the employer's own careers page when we last checked (daily). Confirm on their site before applying.
depending on experience
Job Scope: Responsible for case processing and/or QC of clinical trial ICSRs and postmarket case processing from sanctioned countries.
Triage, Intake, case entry and QC of ICSRs originating from Biogen 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
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 : Bachelors degree in science or healthcare related field
Experience : 4+ years experience in pharmacovigilance
(No Value)
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