Dutch speaking Pharmacovigilance QC Associate

Cognizant is a global leader in technology and consulting services, dedicated to helping businesses transform and innovate. We are committed to fostering a diverse and inclusive workplace where every employee can thrive.

The role requires to Translation & Translation QC of Adverse Event Reports and Data Entry and Data Entry QC (if required) of safety data into safety database. This role also required timely completion of assignment of cases/activities, maintaining quality and timelines and ensuring audit readiness.

Key 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
• Save the Local language source document and Standard AE form in common drive or folder
• 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)
• Anonymizing / Redacting Source Documents and / or Adverse Event (AE) Forms (as applicable)
• Complete the daily case tracking spreadsheet with Local Affiliate Module (LAM) / Argus IDs
• Handling of queries (action items) received from the central processing sites regarding discrepancies in Source Documents, AE form and / or Argus Affiliate / Core database
• Follow up with Country Organization (CO), if required (via queries and action items)
• Generating Follow-Up Action Items for Fatal, Life-Threatening, Serious & Non-Serious cases and for Pregnancy cases (Serious & Non-Serious) & Non-Cases,
• Generate follow-up letter
• Transfer the letters & source documents for Patient Safety Information (PSI) book-in activity to CO via Document Exchange Tool (if applicable)
• Upload source documents and / or AE form in Argus Affiliate / Core database
• Transfer the case to Central site / Case processing team
• Responsible for completion of day-to-day work and process flows within agreed Service Level Agreements (SLAs).
• Prioritization of cases as per Validity & Seriousness (if applicable)
• Anonymizing / Redacting Source Documents and / or Standard Adverse Event (AE) Forms (as applicable)
• Responsible for case QC. Review Translation of Source Documents from European Non-English Language to English in Standard Adverse Event (AE) Form 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 correct it
• To ensure the case translated and/or booked-in by the an associate is medically relevant, complete and accurate as per 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
• Use process guidance documents to check if the relevant adverse event terms and safety data was captured appropriately by the associate in AE Form/safety database
• Identify clinically relevant information missing or error found in the case then facilitate its entry/correction (by revising or routing back) in AE Form/Argus Affiliate / Core
• Providing feedback, documenting it appropriately, monitoring of associate’s performance and closely working with the TCBAs to improve Quality
• To identify and analyze root cause, and suggest appropriate corrective and preventive actions as necessary
• Respond to queries raised by the TCBAs and provide adequate feedback
• Assist with related administrative and procedural activities as per project requirement
• Assists in the training and Mentorship of other Case processing related activities as necessary
• Assists in audits and inspections and must have knowledge of International Conference on Harmonization (ICH)

• 1 year of Pharmacovigilance or relevant clinical experience
• Excellent spoken and written Dutch and English proficiency

• Competitive salary and benefits
• Opportunities for professional growth and development
• Collaborative and innovative work environment
• Commitment to diversity and inclusion

Cognizant is an equal opportunity employer. Your application and candidacy will not be considered based on race, color, sex, religion, creed, sexual orientation, gender identity, national origin, disability, genetic information, pregnancy, veteran status or any other characteristic protected by federal, state or local laws.