Drug Safety Assistant

  • Contract

Company Description

We are proud to be part of the most precious thing on Earth: human life. Applying the technological expertise to the medical knowledge to derive near infallible results comes naturally to Global Pharma Tek, LLC. Global Pharma Tek is a fast-growing premier global pharmaceutical company that provides end-to-end services in pharmaceutical industry round the globe. Global Pharma Tek offers services like Drug Discovery, Clinical Trials, Drug Delivery, Regulatory and Intellectual Property Rights, Marketing and Strategic Human Resourcing. Global Pharma Tek is specialized in providing highly technical pharmaceutical and healthcare solutions and services in a cost effective way around the globe.

We are enterprise-class clinical software and clinical functional services provider, offers unique blend of both clinical trial domain and core IT expertise with thorough understanding of healthcare and pharma industry and regulatory standards. Global Pharma Tek, clinical functional services practice (FSP) enable pharmaceutical and life sciences industry customers realize their vision of safe, effective, and FDA approved delivery of drug at the lowest cost and at the fastest time to market. 

With core technology focus in the areas of statistical programming, business intelligence & data warehousing, enterprise application integration and enterprise architecture development, enterprise resource planning and custom applications development, along with clinical domain expertise, Global Pharma Tek offers a full range of specialized functional clinical & IT in-sourcing, IT projects development, clinical functional & IT projects outsourcing, software enabled services.

Job Description

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 Pharmaceutical Country Offices that are not online with Argus 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 cannot on their own. -----

 

Qualifications

Duration: one (1) year in length. Argus experience preferred. ----- BA degree required with 1-3 years of Safety/Pharamacoviliance Data experience. Argus experience. No Travel and No overtime. This is a 1 year Assignment.

Additional Information

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