Title: Safety Scientist 

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