Department: Quality & Regulatory Compliance (Clinical Operations)

Responsibilities:

• Processing & reporting Adverse event into the Product Safety database for in association with Client’s Marketed and investigational products.
• Perform processing and oversight of adverse event/drug experience reports (serious and non-serious) and other safety related data for marketed products and clinical trials
• Responsible for Adverse event coding using standardized terminology from a medical coding dictionary, such as MedDRA
• To verifying the accuracy and completeness of information for each adverse event report for which he/she is responsible in conjunction with the source documents and ensuring that the activities are performed in a manner consistent with company SOPs.
• Assist in gathering Serious Adverse Events (SAEs) reports in a timely manner in the preparation of both internal and external IND safety reports per company SOPs.
• Process all types of adverse event reports utilizing the safety database.
• Writing case narratives for serious, non-serious and study reports, quality/product complaint reports
• Medical coding into standard dictionaries and writing of narratives based on information provided both on standard forms and from medical records and other documents of diseases and medications.
• Responsible for taking appropriate decisions by applying their knowledge of FDA & ICH-GCP standard regulations to write over all case summary.
• Assist with literature review and article procurement as required
• Generate and work with other team members to send follow up letters or queries to the appropriate reporter using the most expedient mechanism, forwarding to clinical sites where appropriate.
• Communicate/Collaborate with Medical Affairs (MA) Department in cases involving both an ADE and potential Product Quality Complaint component.
• Communicate/Collaborate with licensees, marketing partners, distributors and manufacturers in receipt and transmission of ADE reports (US and Foreign) as per applicable safety data exchange agreements.
• Interact with clinicians, nurses, pharmacists consumers, and marketing partners externally, as well as internal staff at company headquarters to get necessary missing information
• Assessment of case reports for seriousness, causality and expectedness
• Supporting the generation of aggregated safety reports and Data Monitoring Committee (DMC) reviews.
• Responsible for operational pharmacovigilance activities for assigned developmental and marketed products.
• Support the identification of corrections and creation of updates in safety database following medical review.
• Assist with Pharmacovigilance reconciliation of databases and listings (post marketing and clinical trial sources) as required
• Perform retrospective quality review and document findings, and contribute to metric compilation
• Assist with additional Drug Safety activities as required

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: $60,000.00 to $70,000.00 /year

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

• Posted on 08/15/2022