Job location: Budapest, Hungary, 9thDistrict, Mill Park Office Building
Role type: Full time employment
Working hours: 40 hours/ week
Hybrid work mode
Normal office hours
OFFER
- Competitive salary and cafeteria benefits; All You Can Move SportPass (at a discounted price), medical benefits and other perks
- Risk and accident insurance
- Chance to be part of a rapidly expanding organization
- Training and continuous learning and certification opportunities
- Multilingual environment, native colleagues
- Pleasant and inspiring working atmosphere with multicultural community and state-of-the-art technologies
- Easy to access location and modern office building (easy to reach from city centre, 10-15 minute commute)
- Reimbursable language courses
- Team events and Company events (cool and youthful parties with team-games)
- High value awards and recognitions, annual bonus for top performers, and annual salary review
REQUIREMENTS
Minimal Education Qualification: Graduate/Postgraduate/Doctorate degree in Life sciences/ Pharmacy/Medical sciences or equivalent degree
Experience: Freshers to 2 years plus experience in Pharmacovigilance preferred
Language Capability: Good spoken and written English and Italian proficiency (level B2 CEFR (Common European Framework of Reference for Languages) minimum or equivalent) or Native Non-English speaker with education in English and Italian medium
DESCRIPTION
§ 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)
CogHU103
About us
Cognizant (Nasdaq: CTSH) is an AI Builder and technology services provider, building the bridge between AI investment and enterprise value by building full-stack AI solutions for our clients. Our deep industry, process and engineering expertise enables us to build an organization’s unique context into technology systems that amplify human potential, realize tangible returns and keep global enterprises ahead in a fast-changing world. See how at www.cognizant.com or @cognizant.
Additional employment information
Compensation information is accurate as of the date of this posting. Cognizant reserves the right to modify this information at any time, subject to applicable law.
Applicants may be required to attend interviews in person or by video conference. In addition, candidates may be required to present their current state or government issued ID during each interview.
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.
If you have a disability that requires reasonable accommodation to search for a job opening or submit an application, please email [email protected] for roles based in the Americas or [email protected] for roles based in India.
