Job Summary
Serve as a specialist professional in pharmacovigilance within a hybrid work model supporting pharma research and development activities focused on the safe and effective use of medicinal products. Contribute to data driven safety evaluation and collaborate across functions to enhance patient safety outcomes and regulatory compliance.
Responsibilities
Perform end to end case related pharmacovigilance activities that support ongoing pharma research and development and help ensure timely safety reporting to regulatory bodiesReview available clinical and post marketing safety information to identify potential safety signals and contribute to risk assessment activities that protect patientsAnalyze safety data using company systems to detect trends or patterns and escalate relevant findings to medical safety experts for further evaluationDocument all safety case handling steps with clear and accurate narratives that enable transparent audits and inspections by internal and external stakeholdersCollaborate with cross functional research and development teams to integrate safety insights into study design and product lifecycle decisions that advance therapeutic innovationCoordinate with quality and compliance teams to follow current pharmacovigilance procedures and support continuous improvement of standard operating processesSupport preparation of safety sections for regulatory submissions and periodic reports so that product safety profiles are clearly communicated and well justifiedContribute to knowledge sharing sessions with peers to promote consistent case processing practices and strengthen the overall pharmacovigilance capability of the organizationEngage with internal technology and data teams to refine pharmacovigilance tools so that safety data capture and retrieval become more efficient and reliableParticipate in internal audits or readiness activities by providing case related documentation and clarifications that demonstrate strong adherence to pharmacovigilance requirementsAdapt work practices to a hybrid model by using digital collaboration platforms that maintain continuity of pharmacovigilance operations across onsite and remote settingsSupport broader company goals by transforming safety data into meaningful insights that guide responsible use of medicines and create a positive impact on public healthManage personal workload within day shift expectations to ensure all assigned safety activities and timelines are met without the need for travel
Qualifications
Possess a degree in life sciences pharmacy medicine or a related discipline that provides a solid scientific foundation for evaluating drug safety informationDemonstrate two to four years of focused experience in pharma research and development with direct exposure to pharmacovigilance practices and processesApply working knowledge of safety data review tools or databases to manage cases efficiently while maintaining data integrity and traceabilityUtilize familiarity with pharmacovigilance data management concepts to support accurate entry reconciliation and retrieval of safety information when requiredExhibit practical understanding of pharmacovigilance case processing steps including intake coding assessment and follow up activities that align with current regulationsCommunicate clearly in written and spoken form with global stakeholders to ensure that complex safety issues are documented and discussed in an accessible mannerShow commitment to ongoing learning about evolving pharmacovigilance guidelines and research methodologies so professional skills remain current and adaptable
Certifications Required
Desired certification in pharmacovigilance or drug safety such as a recognized pharmacovigilance professional credential
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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Cognizant is een werkgever die gelijke kansen biedt. Je sollicitatie en kandidatuur worden niet beoordeeld op basis van ras, huidskleur, geslacht, religie, levensovertuiging, seksuele geaardheid, genderidentiteit, nationale afkomst, handicap, genetische informatie, zwangerschap, veteranenstatus of enige andere eigenschap die wordt beschermd door federale, regionale of lokale wetgeving.
