Seeking a Safety Scientist responsible for supporting all operational functions within the Global Case Processing Department (Post-Marketing and Clinical Trials), such as Individual Case Safety Report (ICSR) processing and reporting.
Primary Skills: Safety Scientist
Experience: 1-2 years
Degree: Bachelor’s Degree in Biomedical Engineering
Job Responsibilities:
Performing Book-in and Triage of incoming spontaneous, clinical trial and post marketing Individual case safety Reports (ICSRs)
Performing Data Entry and Case processing.
Determination of seriousness, expectedness, and causality of adverse events
Internal and external guidance documents, SOPs, and case processing/coding conventions using ARGUS database.
Critical analysis of relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments.
Drug terminologies according to project specific coding conventions, Package Insert (PI), Investigator Brochure (IB) and Company Core Data sheet (CCDS).
Coding of medical history, drugs and reported adverse event terms in Argus safety database using medical dictionaries: MedDRA, CDD, WHO.
Training new employees with respect to SOPs and company guidelines on specific projects.
Performing investigation, root cause, corrective and preventive actions related to PV associated CAPA findings.
Performing SAE reconciliation between safety and clinical databases.
Accurately MedDRA coding of adverse events.
Taking care of product quality complaints.
Performing Quality control of ICSRs
Qualification:
Bachelor’s degree in Biomedical Engineering or a closely related field