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PRODUCT/DRUG SAFETY COORDINATOR AND CODING SPECIALIST

Zenith LifeScience
South Plainfield, NJ

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Job Details

Full-time
$60,000 - $70,000 a year

Qualifications

Incident reporting compliance
Adverse event reporting
Patient safety and incident reporting systems
Medical terminology

Full Job Description

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 [email protected] for direct consideration or question.

Posted on 06/25/2022

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