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Drug Safety Data Management Specialist

1-3 years
Not Disclosed
10 May 27, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, CPC Certified, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Company Description

Global Pharma Tek, LLC

Global Pharma Tek is a premier global pharmaceutical company dedicated to the most precious thing on Earth: human life. Leveraging technological expertise alongside medical knowledge, we deliver near infallible results. As a fast-growing company, we provide comprehensive services across the pharmaceutical industry worldwide, including:

  • Drug Discovery
  • Clinical Trials
  • Drug Delivery
  • Regulatory and Intellectual Property Rights
  • Marketing and Strategic Human Resourcing

Specialization: Global Pharma Tek excels in delivering highly technical pharmaceutical and healthcare solutions cost-effectively around the globe.

Service Offerings: We offer a unique blend of clinical trial domain and core IT expertise, with a deep understanding of healthcare, pharma industry standards, and regulatory compliance. Our clinical functional services practice (FSP) empowers pharmaceutical and life sciences industries to deliver safe, effective, and FDA-approved drugs swiftly and economically.

Core Technology Focus Areas:

  • Statistical Programming
  • Business Intelligence & Data Warehousing
  • Enterprise Application Integration
  • Enterprise Architecture Development
  • Enterprise Resource Planning
  • Custom Applications Development

Clinical & IT Services:

  • Specialized Functional Clinical & IT In-sourcing
  • IT Projects Development
  • Clinical Functional & IT Projects Outsourcing
  • Software-Enabled Services

Job Description

Position: Pharmacovigilance Data Specialist

Responsibilities:

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

Qualifications

  • Education: BA degree required.
  • Experience: 1-3 years of Safety/Pharmacovigilance Data experience.
  • Skills: Experience with Argus.

Additional Information

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


For more information or to apply for this position, please visit our website or contact our recruitment team.