Czech or Slovakian Speaking Pharmacovigilance Associate

1 month ago

Budapest, Hungary Cognizant Technology Solutions Full time

Czech or Slovakian Speaking Pharmacovigilance Associate

 

 

 

 

Location: Budapest, Hungary – Mill Park office building

Job type: permanent

Hybrid work mode: on site work once per month

Work schedule: Monday to Friday from 9:00 until 17:30

 

 

 

What we offer:

 

·       Competitive salary + Annual bonus system + Cafeteria package

·       Relocation package available

·       Free or discounted medical services at a private clinic

·       Risk and accident insurance

·       Online trainings

·       Language course reimbursement

·       All You can Move Sportpass + other discount fitness options

·       Easy to access location and fancy, modern office building in Budapest

 

 

Responsibilities:

 

·      Receipt / Download / Accepting of cases from Document Exchange Tool or electronically (or any other source)

·      Translation of all relevant European Non-English information from source documents to English (if required) and updating relevant fields in Standard Adverse Event (AE) form

·      Anonymization/Redaction (if applicable)

·      Perform reconciliation of cases received with number of cases translated and completed

·       Review Translation of Source Documents from European Non-English Language to English in Standard Adverse Event (AE) Form

·       Use process guidance documents to check if the relevant adverse event terms and safety data was translated and captured appropriately by the Translation Associate (TA) in Standard AE form

·       Identify clinically relevant information missing from the Standard AE Form and facilitate its entry in it

·       Providing feedback, monitoring of TA’s performance and closely working with the TAs to improve Quality

·      To identify and analyze root cause, and suggest appropriate corrective and preventive actions for quality issues as necessary

·     Assists in the training and Mentorship of other TAs and TQCs and also in the case book-in related activities as necessary

·       Mailbox management for applicable COs

·       Triage of cases for validity and seriousness (if applicable)

·       Perform Duplicate Search

·       Book-in Initial case / Follow-up to existing case depending upon the duplicate search results

·       Data entry of mandatory information into Argus Affiliate / Core database

·       Self / Peer Quality Check (QC) of the cases before routing to central processing (as applicable)

·       Follow up with Country Organization (CO), if required (via queries and action items)

·       Responsible for case QC. Review and verify data processed in Argus Affiliate (AA) or Argus Core against source documents and AE forms. If error found, revise data or route back to Data Entry team to correct

·       To ensure the case booked-in by the Case Receipt and Book-in Associate (CBA) is medically relevant, complete and accurate as per client Standard Operating Procedures (SOPs) and procedures in Argus Affiliate / Core

·       Ensure scientific rigor through accurate check of complete and consistent data entry of adverse event reports from source documents with emphasis on timelines and quality

·       Providing feedback, monitoring of CBA’s performance and closely working with the CBAs to improve Quality

·       Respond to queries raised by the CBAs and provide adequate feedback

·       Assists in the training and Mentorship of other Case book-in related activities as necessary

·       Assists in audits and inspections and must have knowledge of International Conference on

 

Your profile:

 

·       Both English (written and spoken) combined with Czech or Slovakian (written) language knowledge is a must have on minimum B2 level

·       Degree in Life Sciences (bachelors or masters) is a MUST, please only apply if you have a finished diploma

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