Department: Quality & Regulatory Compliance (Clinical Operations)

Responsibilities:

• Executed receipt of Drug Safety phone calls and complete telephone AE form
• Created phone call communication logs into the database and triage of cases as needed.
• Implement and executed QC on key fields of serious cases
• Executed case assessment (review events, determine labeledness, identify co-manifestations, review coding, determine causality
• Created clear concise clinical case narratives, review and updated auto-narrative as needed.
• Created company pharmacovigilance comments for causality assessment, dechallenge/rechallenge determinations and performed event rankings.
• Perform case handling including receipt, book-in, assessment, duplicate-check, seriousness, expectedness, case processing, Narratives, Follow up’s, Quality check and Submissions.
• Review and process device cases, clinical trial cases, and potential litigation cases received from different sources.
• Perform accurate coding of Adverse Event and product for all incoming serious and non-serious cases using medical terminology via MedDRA (Medical Dictionary for Regulatory Activities) and WHO Drug Dictionary.
• Quality review of ICSR’s concentrating primarily on Narratives, Product coding, Medical coding for any possible discrepancies with the related source documents and sending reports related to the same to the concerned product managers and case processors.
• Electronic reporting (E2B) of all necessary reports, expedited safety reports, ensuring successful timely submission and collating acknowledgments of ICSRs from Regulatory Authorities and Business Partners.
• Determined follow-up needs for AE reports.
• Reviewed and updated generated follow-up letters as appropriate
• Leveraged professional background in pharmacovigilance to support Quality Assurance through reviewing documentation, client agreements, and regulatory guidelines.
• Maintained knowledge of company/client product safety profiles and manufacturing processes to respond to all medical and technical inquiries related to pharmacovigilance.

Educational and/or experience requirements:

• A minimum degree of bachelor’s or higher degree in pharmacy or closely related field
• 1-2 years experience in Adverse Event reporting
• Hands on experience with ARGUS or ARISg
• Good Understanding of MedDRA & WHO drug dictionary

Job Type: Full-time

Salary: $70,000.00 to $80,000.00 /year

Please send profile at info@zenithlifescience.com for direct consideration or question.

• Posted on 08/16/2022