The company needs to ensure timely and accurate entry of adverse event reports into their global safety database, specifically utilizing the Argus system, to maintain compliance and facilitate the correct forwarding of information to relevant teams.
Requirements
- Argus experience is required.
- Argus, Outlook, Excel.
- Data entry-Argus
- Argus experience is REQUIRED.
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 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.
Other
- BA degree required with 1-3 years of Safety/Pharamacoviliance Data experience.
- Argus experience.
- No Travel.
- Undergraduate Degree is REQUIRED.
