Major accountabilities:<\/p>\n
\tManage the collection, processing, documentation, reporting and follow-up of all adverse event reports for all Novartis products from Clinical Trials, Non-interventional Studies, Patient Oriented Program (POPs), Literature, Spontaneous Reports, and any other source of information.
\n\tTranscribe, translate, and enter data from source documents into safety systems accurately and consistently with focus quality and on timeliness. When case processing activities are externalized, liaise with the respective External Service Providers to ensure Novartis Procedures\u2019 compliance.
\n\tManage reporting\/submission\/distribution of safety reports\/updates\/information (e.g., SAE, SR, IN\/SUSAR, PSUR, Biannual SUSAR Listing, DSUR) to Local Health Authorities (LHA) and\/or clinical operations in cooperation with other Country Organization Departments.
\n\tDevelop, update, and implement local procedures to ensure compliance with Patient Safety global procedures and national requirements.
\n\tInteract and collaborate with other departments (such as Medical Affairs, Marketing, Patient Engagement, etc.) to ensure that any projects\/ initiatives that potentially involve safety data collection (POPs, DEAs, SM\/SML, etc.) follow the Novartis vigilance requirements.
\n\tManagement and distribution of vigilance clauses to other departments (such as Legal, Procurement, etc.) to be included in local agreements if necessary
\n\tAdvice the owners of local contracts\/ agreements with impact in the vigilance system, about the vigilance provisions to be included, as required per Novartis procedures and\/or applicable regulations.
\n\tEnsure compliance with the commitments disposed in the contracts\/ agreements. Ensure the applicable local contracts\/ agreements are tracked in the respective Pharmacovigilance Agreement SharePoint. Ensure any significant departure from the standard vigilance templates are communicated and endorsed by the global PS Alliance group.
\n\tPerform reconciliation with other departments (e.g., Medical Information, Quality Assurance, and Third-party contractors, as applicable) for potential AEs resulting from medical inquiries, quality related complaints and other sources.
\n\tManagement and maintenance of all relevant local Patient Safety databases
\n\tEnsure that relevant local literature articles are screened as appropriate.
\n\tPrepare and submit KPI reports on compliance in a timely manner including identification of root cause(s) for late reporting to LHA, development and implementation of corrective action(s) as needed.
\n\tDevelop and update training materials for vigilance and ensure training of Country Organization associates on relevant Patient Safety procedures for AE reporting, including field force and third-party contractors, as applicable.
\n\tEnsure support to the internal audits, LHA inspections and implementation of the respective CAPA plan
\n\tDeputy QPPV for Kenya, Burundi, Djibouti, Eritrea, Rwanda, Tanzania
\n\tOther agreed tasks assigned by manager<\/p>\n
Key performance indicators:<\/p>\n
\tAdherence to Novartis policy and guidelines
\n\tProject and stakeholder feedback
\n\tOperational risk mitigation and audit\/inspection findings
\n\tQuality and timely reporting of KPI and safety reports\/updates
\n\tResults of audits\/inspections
\n\tInternal and external customer satisfaction<\/p>\n
Minimum Requirements:<\/p>\n
\tEducation: Care Sciences Professional (e.g., Nurse, Pharmacist), life science degree or equivalent training and experience.<\/p>\n
Apply Through:<\/p>\n
www.novartis.com<\/p>\n","protected":false},"author":2,"featured_media":0,"template":"","meta":{"_promoted":"","_job_location":"","_application":"http:\/\/www.novartis.com","_company_name":"Novartis","_company_website":"https:\/\/www.novartis.com","_company_tagline":"Novartis provides healthcare solutions that improve and extend people\u2019s lives. We use science-based innovation to address some of society\u2019s most challenging healthcare issues. We discover and develop breakthrough treatments and find new ways to deliver them to as many people as possible. Our com... read morepany is focused on industry-leading divisions with innovation power and global scale: pharmaceuticals, eye care and generic medicines Novartis is headquartered in Basel, Switzerland. Novartis Group companies employ approximately 120,000 associates and its products are available in more than 180 countries around the world. Our Mission and Vision Our mission is to discover new ways to improve and extend people\u2019s lives. Our vision is to be a trusted leader in changing the practice of medicine. Our Values Strong values define our culture and help us execute the Novartis strategy in line with our mission and vision.","_company_twitter":"","_company_video":"","_filled":0,"_featured":0,"_remote_position":0,"_job_salary":"","_job_salary_currency":"","_job_salary_unit":""},"job_listing_region":[692],"job-categories":[693,714],"job-types":[687],"class_list":{"0":"post-92572","1":"job_listing","2":"type-job_listing","3":"status-publish","4":"hentry","5":"job_listing_region-nairobi","7":"job-type-full-time"},"jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/jobs.dataaxisnode.com\/kenya\/wp-json\/wp\/v2\/job-listings\/92572","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/jobs.dataaxisnode.com\/kenya\/wp-json\/wp\/v2\/job-listings"}],"about":[{"href":"https:\/\/jobs.dataaxisnode.com\/kenya\/wp-json\/wp\/v2\/types\/job_listing"}],"author":[{"embeddable":true,"href":"https:\/\/jobs.dataaxisnode.com\/kenya\/wp-json\/wp\/v2\/users\/2"}],"wp:attachment":[{"href":"https:\/\/jobs.dataaxisnode.com\/kenya\/wp-json\/wp\/v2\/media?parent=92572"}],"wp:term":[{"taxonomy":"job_listing_region","embeddable":true,"href":"https:\/\/jobs.dataaxisnode.com\/kenya\/wp-json\/wp\/v2\/job_listing_region?post=92572"},{"taxonomy":"job_listing_category","embeddable":true,"href":"https:\/\/jobs.dataaxisnode.com\/kenya\/wp-json\/wp\/v2\/job-categories?post=92572"},{"taxonomy":"job_listing_type","embeddable":true,"href":"https:\/\/jobs.dataaxisnode.com\/kenya\/wp-json\/wp\/v2\/job-types?post=92572"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}