Pharmacovigilance associate (case processing, colombia) page is loaded pharmacovigilance associate (case processing, colombia) apply remote type office or home locations colombia, bogota time type full time posted on posted 2 days ago job requisition id jr133549 pharmacovigilance associate (case processing, colombia) icon plc is a world-leading healthcare intelligence and clinical research organization. we’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development we are currently seeking a pharmacovigilance associate to join our diverse and dynamic team. as a pharmacovigilance associate at icon, you will play a vital role in monitoring and ensuring the safety of pharmaceutical products by collecting, analyzing, and reporting adverse event information. your attention to detail and understanding of regulatory requirements will be essential in supporting the organization’s commitment to patient safety and compliance. what you will be doing: - collecting and reviewing adverse event reports to ensure accurate and timely reporting in accordance with regulatory guidelines. - conducting signal detection and risk assessment activities to identify potential safety issues. - collaborating with cross-functional teams to support safety-related inquiries and investigations. - maintaining up-to-date knowledge of pharmacovigilance regulations and industry best practices. - assisting in the preparation of safety reports and regulatory submissions. your prof...
Senior drug safety associate - homebased in switzerland only as a senior drug safety associate you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. the role is dedicated to an innovative pharma that currently develops and manufactures prescription biopharmaceutical medications in multiple therapeutic areas including oncology, inflammation, and autoimmunity. the senior drug safety associate will be responsible for processing and oversight of adverse event/drug experience reports (serious and non-serious) and other safety related data for marketed products and clinical trials. the position will be responsible for leading case management lifecycle from receipt through case completion. what you will be doing: perform processing and oversight of adverse event/drug experience reports (serious and non-serious) and other safety related data for marketed products and clinical trials. completion of the case management lifecycle including but not limited to: intake, triage, book-in, data entry, peer/quality review, follow-up and submissions. perform case processing (including case deactivations) and data gathering tasks within argus safety database and other systems (i.e. edc systems). assist with literature review and article procurement as required. perform retrospective quality review and document findings, and contribute to metric compilation assist with business partner and other query management. represent pharmacovigilance on project teams. assist with capa/audit or inspection finding investigations a...
Pharmacovigilance associate (case processing, colombia) page is loaded pharmacovigilance associate (case processing, colombia) apply remote type office or home locations colombia, bogota time type full time posted on posted 2 days ago job requisition id jr133549 pharmacovigilance associate (case processing, colombia) icon plc is a world-leading healthcare intelligence and clinical research organization. we’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development we are currently seeking a pharmacovigilance associate to join our diverse and dynamic team. as a pharmacovigilance associate at icon, you will play a vital role in monitoring and ensuring the safety of pharmaceutical products by collecting, analyzing, and reporting adverse event information. your attention to detail and understanding of regulatory requirements will be essential in supporting the organization’s commitment to patient safety and compliance. what you will be doing: collecting and reviewing adverse event reports to ensure accurate and timely reporting in accordance with regulatory guidelines. conducting signal detection and risk assessment activities to identify potential safety issues. collaborating with cross-functional teams to support safety-related inquiries and investigations. maintaining up-to-date knowledge of pharmacovigilance regulations and industry best practices. assisting in the preparation of safety reports and regulatory submissions. your profile: bachelor's degree in life scien...
Pharmacovigilance associate (case processing, colombia) icon plc is a world-leading healthcare intelligence and clinical research organization. we’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. we are currently seeking a pharmacovigilance associate to join our diverse and dynamic team. as a pharmacovigilance associate at icon, you will play a vital role in monitoring and ensuring the safety of pharmaceutical products by collecting, analyzing, and reporting adverse event information. your attention to detail and understanding of regulatory requirements will be essential in supporting the organization’s commitment to patient safety and compliance. **what you will be doing:** + collecting and reviewing adverse event reports to ensure accurate and timely reporting in accordance with regulatory guidelines. + conducting signal detection and risk assessment activities to identify potential safety issues. + collaborating with cross-functional teams to support safety-related inquiries and investigations. + maintaining up-to-date knowledge of pharmacovigilance regulations and industry best practices. + assisting in the preparation of safety reports and regulatory submissions. **your profile:** + bachelor's degree in life sciences, pharmacy, or a related field; advanced degree preferred. + experience in pharmacovigilance, drug safety, or a related area, preferably within a clinical or pharmaceutical environment. + strong analytical ski...
Home based icon plc is a world-leading healthcare intelligence and clinical research organization. we’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development we are currently seeking a pharmacovigilance associate to join our diverse and dynamic team. as a pharmacovigilance associate at icon, you will play a vital role in monitoring and ensuring the safety of pharmaceutical products by collecting, analyzing, and reporting adverse event information. your attention to detail and understanding of regulatory requirements will be essential in supporting the organization’s commitment to patient safety and compliance. what you will be doing: - collecting and reviewing adverse event reports to ensure accurate and timely reporting in accordance with regulatory guidelines. - conducting signal detection and risk assessment activities to identify potential safety issues. - collaborating with cross-functional teams to support safety-related inquiries and investigations. - maintaining up-to-date knowledge of pharmacovigilance regulations and industry best practices. - assisting in the preparation of safety reports and regulatory submissions. your profile: - bachelor's degree in life sciences, pharmacy, or a related field; advanced degree preferred. - experience in pharmacovigilance, drug safety, or a related area, preferably within a clinical or pharmaceutical environment. - strong analytical skills with attention to detail in data collection and reporting. - ...
Pharmacovigilance associate (case processing, colombia) icon plc is a world-leading healthcare intelligence and clinical research organization. we’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. we are currently seeking a pharmacovigilance associate to join our diverse and dynamic team. as a pharmacovigilance associate at icon, you will play a vital role in monitoring and ensuring the safety of pharmaceutical products by collecting, analyzing, and reporting adverse event information. your attention to detail and understanding of regulatory requirements will be essential in supporting the organization’s commitment to patient safety and compliance. what you will be doing: collecting and reviewing adverse event reports to ensure accurate and timely reporting in accordance with regulatory guidelines. conducting signal detection and risk assessment activities to identify potential safety issues. collaborating with cross-functional teams to support safety-related inquiries and investigations. maintaining up-to-date knowledge of pharmacovigilance regulations and industry best practices. assisting in the preparation of safety reports and regulatory submissions. your profile: bachelor's degree in life sciences, pharmacy, or a related field; advanced degree preferred. experience in pharmacovigilance, drug safety, or a related area, preferably within a clinical or pharmaceutical environment. strong analytical skills with attention to detail in data collection and re...
Senior cdc - homebased - mexico icon plc is a world-leading healthcare intelligence and clinical research organization. we’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. we are currently seeking a senior clinical data coordinator to join our diverse and dynamic team. as a clinical data coordinator at icon, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies. **what you will be doing** + create and maintain detailed data management plans and documentation, ensuring compliance with industry standards and regulatory requirements. + participate in the identification and resolution of data discrepancies and issues, working to streamline data flow and enhance data quality throughout the study lifecycle. + collaborate closely with cross-functional teams, including clinical operations and biostatistics, to develop and execute data management strategies tailored to specific studies. + perform other project activities as required in order to ensure that study timelines are met (for example, filing and archiving of study documentation , dispatching of queries to investigator sites for resolution, etc.). + mentor junior data coordinators, providing expert guidance on data reconciliation, coding, and cleaning procedures. **your profile** + bachelor's degree in a relevant field, such as life sciences or healthcare. ...
Pharmacovigilance associate (case processing, colombia) icon plc is a world-leading healthcare intelligence and clinical research organization. we’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. we are currently seeking a pharmacovigilance associate to join our diverse and dynamic team. as a pharmacovigilance associate at icon, you will play a vital role in monitoring and ensuring the safety of pharmaceutical products by collecting, analyzing, and reporting adverse event information. your attention to detail and understanding of regulatory requirements will be essential in supporting the organization’s commitment to patient safety and compliance. **what you will be doing:** + collecting and reviewing adverse event reports to ensure accurate and timely reporting in accordance with regulatory guidelines. + conducting signal detection and risk assessment activities to identify potential safety issues. + collaborating with cross-functional teams to support safety-related inquiries and investigations. + maintaining up-to-date knowledge of pharmacovigilance regulations and industry best practices. + assisting in the preparation of safety reports and regulatory submissions. **your profile:** + bachelor's degree in life sciences, pharmacy, or a related field; advanced degree preferred. + experience in pharmacovigilance, drug safety, or a related area, preferably within a clinical or pharmaceutical environment. + strong analytical ski...
Pharmacovigilance associate (case processing, colombia) icon plc is a world-leading healthcare intelligence and clinical research organization. we’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development we are currently seeking a pharmacovigilance associate to join our diverse and dynamic team. as a pharmacovigilance associate at icon, you will play a vital role in monitoring and ensuring the safety of pharmaceutical products by collecting, analyzing, and reporting adverse event information. your attention to detail and understanding of regulatory requirements will be essential in supporting the organization’s commitment to patient safety and compliance. what you will be doing: - collecting and reviewing adverse event reports to ensure accurate and timely reporting in accordance with regulatory guidelines. - conducting signal detection and risk assessment activities to identify potential safety issues. - collaborating with cross-functional teams to support safety-related inquiries and investigations. - maintaining up-to-date knowledge of pharmacovigilance regulations and industry best practices. - assisting in the preparation of safety reports and regulatory submissions. your profile: - bachelor's degree in life sciences, pharmacy, or a related field; advanced degree preferred. - experience in pharmacovigilance, drug safety, or a related area, preferably within a clinical or pharmaceutical environment. - strong analytical skills with attention to...
As a clinical research associate you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. what you will be doing: serve as the primary point of contact between investigational sites and the sponsor conduct all types of site visits, including selection, initiation, routine monitoring, and close-out ensure site compliance with ich-gcp, sops, and regulations maintain up-to-date documentation in ctms and etmf systems support and track site staff training and maintain compliance records monitor patient safety, ensuring timely and accurate ae/sae/pqc reporting support subject recruitment and retention efforts at the site level oversee drug accountability and ensure proper storage, return, or destruction resolve data queries and drive timely, high-quality data entry document site progress and escalate risks or issues to the clinical team assist in tracking site budgets and ensuring timely site payments (as applicable) collaborating with cross-functional partners including ctas, ltms, and ctms you are: a graduate with a bachelor’s degree in life sciences or equivalent, or a qualified rn eligible to work in united states without visa sponsorship a clinical research professional with 2+ years of on-site monitoring experience in the pharmaceutical or cro industry experienced across multiple therapeutic areas, including immunology preferred. proficient in ich-gcp, local regulatory requirements, and clinical systems like ctms and etmf a clear communicator, problem-solver, and collaborative team player willing an...
Job summary icon plc is a world-leading healthcare intelligence and clinical research organization. we're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. we are currently seeking a pharmacovigilance associate to join our diverse and dynamic team. as a pharmacovigilance associate at icon, you will play a vital role in monitoring and ensuring the safety of pharmaceutical products by collecting, analyzing, and reporting adverse event information. our success depends on the quality of our people. that's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. at icon, inclusion & belonging are fundamental to our culture and values. we're dedicated to providing an inclusive and accessible environment for all candidates. interested in the role, but unsure if you meet all of the requirements? we would encourage you to apply regardless – there's every chance you're exactly what we're looking for here at icon. responsibilities - collecting and reviewing adverse event reports to ensure accurate and timely reporting in accordance with regulatory guidelines. - conducting signal detection and risk assessment activities to identify potential safety issues. - collaborating with cross-functional teams to support safety-related inquiries and investigations. - maintaining up-to-date knowledge of pharmacovigilance regulations and industry best practices. - assisting in the preparation of safety reports and regulatory sub...
Senior cdc - homebased - mexico icon plc is a world-leading healthcare intelligence and clinical research organization. we’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. we are currently seeking a senior clinical data coordinator to join our diverse and dynamic team. as a clinical data coordinator at icon, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies. **what you will be doing** + create and maintain detailed data management plans and documentation, ensuring compliance with industry standards and regulatory requirements. + participate in the identification and resolution of data discrepancies and issues, working to streamline data flow and enhance data quality throughout the study lifecycle. + collaborate closely with cross-functional teams, including clinical operations and biostatistics, to develop and execute data management strategies tailored to specific studies. + perform other project activities as required in order to ensure that study timelines are met (for example, filing and archiving of study documentation , dispatching of queries to investigator sites for resolution, etc.). + mentor junior data coordinators, providing expert guidance on data reconciliation, coding, and cleaning procedures. **your profile** + bachelor's degree in a relevant field, such as life sciences or healthcare. ...
As a cta you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. you will be partnering with one of the worlds premier biopharmaceutical companies. working across a vast portfolio of medicines and vaccines this company has, over centuries created a strong heritage of delivering innovative treatments and preventive medicines globally. what you will be doing: cta assists in the coordination and administration of the study activities from the start up to execution and close out, and within the local study team to ensure quality and consistency of interventional study deliverables to time, cost and quality objectives - collects, assists in preparation, reviews and tracks documents for the application process as well as coordination and tracking of study materials and equipment - assist in submission of proper application/documents to ec/irb and, where appropriate to regulatory authorities - interfaces with investigators, external service providers and cras during the document collection process - local administrative main contact and works closely with the cras and/or the lsad for the duration of the study - set-up and maintenance of the local etmf and isf including document tracking in accordance with ich-gcp and local requirements - ensures essential documents are uploaded in a timely manner to maintain the etmf “inspection readiness” and study documents are ready for final archiving and completion of local part of the etmf and supports the cra in the close out activities for the isf - prepa...
Job title: pharmacovigilance associate job location: bogotá, bogota, colombia job location type: on-site job contract type: permanent job seniority level: home based icon plc is a world-leading healthcare intelligence and clinical research organization. we’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. we are currently seeking a pharmacovigilance associate to join our diverse and dynamic team. as a pharmacovigilance associate at icon, you will play a vital role in monitoring and ensuring the safety of pharmaceutical products by collecting, analyzing, and reporting adverse event information. your attention to detail and understanding of regulatory requirements will be essential in supporting the organization’s commitment to patient safety and compliance. what you will be doing: collecting and reviewing adverse event reports to ensure accurate and timely reporting in accordance with regulatory guidelines. conducting signal detection and risk assessment activities to identify potential safety issues. collaborating with cross-functional teams to support safety-related inquiries and investigations. maintaining up-to-date knowledge of pharmacovigilance regulations and industry best practices. assisting in the preparation of safety reports and regulatory submissions. your profile: bachelor's degree in life sciences, pharmacy, or a related field; advanced degree preferred. experience in pharmacovigilance, drug safety, or a related area, preferably within a clini...
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