Job Summary
Serve as a Senior Process Executive in pharmacovigilance within a hybrid work model performing high quality safety case activities that rely on strong pharma research and development experience. Apply structured scientific methods to evaluate safety data support compliant reporting and help protect patient well being while enabling safe and effective use of healthcare products across global markets.
Responsibilities
Perform end to end safety case processing activities by reviewing source documents coding relevant information and preparing case narratives to support accurate and timely pharmacovigilance reportingExecute medical and scientific assessments of safety data by applying pharma research and development knowledge to identify potential safety issues and trends that may impact patient well beingMaintain consistent data quality in safety databases by performing detailed data entry checks query resolutions and reconciliation activities aligned with sponsor and regulatory expectationsConduct routine case follow up activities by tracking missing information coordinating with internal teams and updating case records to improve completeness and clinical usefulness of safety dataApply established pharmacovigilance procedures by adhering to global regulations and internal standard operating processes to minimize compliance risk and support successful client auditsCollaborate with cross functional colleagues in clinical operations medical information and quality units to ensure that safety information flows accurately and supports unified patient safety decisionsUtilize domain exposure in pharmacovigilance data management to interpret coding conventions and data structures that enhance consistency and usability of stored safety informationContribute to continuous process improvement by suggesting practical changes to templates checklists and workflows that reduce rework and increase case throughput within the day shift scheduleSupport preparation of safety metrics and summary reports by extracting key indicators from case data that help client teams monitor performance and identify emerging safety signalsEngage in regular training and knowledge refresh sessions to stay aligned with evolving pharmacovigilance regulations client procedures and best practices in pharma research and developmentAdhere to hybrid work and data confidentiality protocols by following secure handling guidelines and using approved systems to protect sensitive health and product informationCommunicate clearly with team members and supervisors about workload status data issues and timeline risks to enable proactive planning and reliable delivery for client projectsContribute to knowledge sharing within the team by documenting case handling nuances and lessons learned that help colleagues manage complex pharmacovigilance scenarios more efficiently
Qualifications
Possess hands on experience in pharma research and development activities that support evidence based evaluation of safety information and enhance scientific rigor in daily pharmacovigilance workDemonstrate practical exposure or understanding of pharmacovigilance data management processes that involve case intake coding standards and database handling in a regulated environmentExhibit working knowledge or experience in pharmacovigilance case processing including triage data entry narrative preparation and case closure within agreed timelinesHold a degree in pharmacy life sciences medicine or a related discipline that provides a strong foundation in drug development principles and clinical research methodologyShow proven ability to interpret clinical and scientific documents such as clinical study reports literature articles and medical records to derive accurate and meaningful safety insightsDisplay strong written and verbal communication skills that support clear documentation of safety cases and effective collaboration with global stakeholders in a hybrid work settingBring two to four years of relevant professional experience in pharmacovigilance clinical research or related safety focused roles that demonstrate readiness for a senior process executive positionApply structured analytical thinking and attention to detail to maintain high data integrity prevent avoidable errors and support reliable downstream safety analyses for client organizations
Certifications Required
Preferred certifications include Drug Safety and Pharmacovigilance Certificate or Good Clinical Practice Certification
Over Cognizant
Cognizant (NASDAQ: CTSH) is een bouwer van AI-oplossingen en een leverancier van technologiediensten. Wij slaan de brug tussen AI-investeringen en ondernemingswaarde door het bouwen van full-stack AI-oplossingen voor onze klanten. Onze diepgaande kennis van sectoren, processen en engineering stelt ons in staat om de unieke context van een organisatie te verankeren in technologische systemen. Deze systemen versterken het menselijk potentieel, realiseren tastbare resultaten en geven wereldwijde ondernemingen een voorsprong in een snel veranderende wereld. Ontdek hoe op cognizant.ai of @cognizant.
Aanvullende arbeidsinformatie
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