Job location: Budapest, Hungary, 9thDistrict, Mill Park Office Building
Role type: Full time employment
Maternity cover contract
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 German proficiency (level B2 CEFR (Common European Framework of Reference for Languages) minimum or equivalent) or Native Non-English speaker with education in English and German 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)
コグニザントのコミュニティ
コグニザントは、クライアントのビジネス、運営、技術モデルをデジタル時代に合わせて変革する、世界有数のプロフェッショナルサービス企業の一つです。私たちの独自の業界ベースのコンサルティングアプローチは、クライアントがより革新的で効率的なビジネスを構想し、構築し、運営するのを支援します。米国に本社を置くコグニザント（NASDAQ-100のメンバーであり、Forbesの2024年世界最高の雇用者の一つ）は、常に世界で最も称賛される企業の一つに挙げられています。コグニザントがどのようにしてクライアントがデジタルでリードするのを支援しているかについては、www.cognizant.comをご覧ください。
- コグニザントは世界中に300,000+上の社員を擁するグローバルな会社会社です。
- 私たちはより良い方法を考えるだけでなく、それを実現していきます。
- 私たちは正しいことを行うことで、社員、顧客、会社、地域社会に貢献します。
- キャリアを築いていくことができる革新的な環境を育んでいきます。
コグニザントについて
コグニザント（Nasdaq-100: CTSH）は世界有数のプロフェッショナル・サービス企業であり、企業がテクノロジーの近代化、プロセスの再構築、エクスペリエンスの変革を実現し、変化の激しい世界で優位に立てるよう支援しています。
コグニザントは機会均等雇用を実践しています。応募および候補者としての選考は、人種、肌の色、性別、宗教、信条、性的指向、性自認、国籍、障がい、遺伝情報、妊娠、退役軍人としての地位、または連邦法、州法、もしくは地方自治体の法律で保護されているその他の特性に基づいて行われることはありません。
求人情報の検索や応募書類の提出に配慮を必要とする障害をお持ちの方は、[email protected] までご要望と連絡先をお知らせください。
免責事項
報酬情報は、この掲載日現在のものです。コグニザントは、適用される法律に従い、いつでもこの情報を修正する権利を有します。
応募者は面接に直接またはビデオ会議で出席する必要がある場合があります。また、各面接時に身分証明書の提示を求められる場合があります。