Clinical Trial Consultant II

Job Description

Job Summary:

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

Duties and 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 (Clinical Trials) cases.

Education and Experience:

• Bachelor’s degree in science or healthcare related field.
• 4+ years experience in pharmacovigilance.

Knowledge, Skills and Abilities:

• 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.

Interview Process:

• Round 1: Initial interview.
• Round 2: Panel interview.
• Round 3: Additional discussion, if required.