Instagram
youtube
Facebook

Drug Safety Data Management Specialist

1-3 years
Not Disclosed
15 June 11, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Company Description

Global Pharma Tek, LLC is a rapidly growing premier global pharmaceutical company dedicated to advancing human life through the application of technological expertise to medical knowledge. We provide end-to-end services in the pharmaceutical industry worldwide, specializing in Drug Discovery, Clinical Trials, Drug Delivery, Regulatory and Intellectual Property Rights, Marketing, and Strategic Human Resourcing. Our mission is to offer highly technical pharmaceutical and healthcare solutions and services in a cost-effective manner, leveraging our expertise and understanding of industry standards.

We specialize in enterprise-class clinical software and clinical functional services, offering a unique blend of clinical trial domain knowledge and core IT expertise. Our Clinical Functional Services Practice (FSP) enables pharmaceutical and life sciences industry customers to achieve safe, effective, and FDA-approved drug delivery at the lowest cost and shortest time to market.

Job Description

Job Title: Safety/Pharmacovigilance Data Entry Specialist

Responsibilities:

  • Enter relevant information into the global safety database for initial or follow-up cases received via paper, fax, or email.
  • Perform quality checks and initial assessments on cases received from suppliers via paper, email, or fax.
  • Accept E2B cases through the Argus Electronic Submissions Module (ESM) from European Health Authorities on behalf of Pfizer Country Offices.
  • Monitor electronic mailboxes and Argus ESM to ensure timely acceptance of Adverse Event (AE) Reports.
  • Perform data entry into databases as required.
  • Ensure accurate coding of events and drugs for cases forwarded to relevant Therapeutic Area Teams and Licensing Groups.
  • Upload AE reports to the Drop in Data Entry II application on behalf of country offices unable to do so independently.

Qualifications:

  • Bachelor's degree required.
  • 1-3 years of experience in Safety/Pharmacovigilance Data.
  • Experience with Argus.

Additional Information

All your information will be kept confidential according to EEO guidelines.