OBJECTIVE OF ROLE<\/p>\n
\tTo support the SA Commercial Business to realize the commercial strategy and to achieve the annual targeted growth and revenue through successful new product introductions and maintenance of current product portfolio in the South Africa and South African Development Community (SADC) region, by ensuring successful Marketing Authorization and variation approval from the SAHPRA and Regulatory Authorities of the SADC member states within the committed timeframe.
\n\tThe role undertakes responsibility for compliance with the Regulatory \/ Pharmacovigilance Requirements for the New Product Launch Pipeline and the existing product portfolio in the region, through the successful completion of assigned activities according to the South African and SADC Regulatory plan.
\n\tTo provide support to the Pharmacovigilance (PV) function of the SA Regulatory Affairs department in the receipt, assessment, processing, and reporting of Individual Case Safety reports (ICSRs) in accordance with PV procedures and PV legislation by ensuring compliance with Regulatory bodies, affiliates, and partners within the stipulated timelines<\/p>\n
KEY RESPONSIBILITIES<\/p>\n
\u00a0PHARMACOVIGILANCE SUPPORT<\/p>\n
\tICSRs (Individual Case Safety Reports)
\n\tPerforming assessment of adverse event case reports.
\n\tAct as case owner for assigned ICSRs to ensure accurate completion of data entry (DE), data review (DR), and regulatory reporting (RR), in line with current SOPs.
\n\tThe PVO acts as a product owner for products under the remit of Pharmacare, supporting the PV Scientists with literature management and aggregate report preparation.
\n\tMaintain a high standard of case quality.
\n\tThe PVO is responsible for providing a root cause analysis for any late reporting submissions.
\n\tManagement and prioritization of individual workload while maintaining good documentation practices (GDP).
\n\tHighlighting any safety-related issues to the attention of the management team.
\n\tPerform pharmacovigilance checks\/evaluations of the Quality Assurance database (Track-wise).
\n\tReconciliation
\n\tReconciliation of all adverse event reports received by PV from internal stakeholders (QA\/MI and ACC).
\n\tReconciliation of all adverse event reports received from PV service providers, affiliates, distributors, and license partners monthly, quarterly, or biannually as described in the Safety Data Exchange Agreement (SDEA).
\n\tQuality Systems Management
\n\tSupport preparation of SOPs, WIs, and product safety reviews
\n\tRaising compliance cards for late cases reported to Pharmacare by service providers, affiliates, distributors, and license partners.
\n\tEnsure all allocated CAPAs, Deviations, and Actions are closed on time, on Track wise. \u00a0Aggregate Reporting and Regulatory Intelligence
\n\tkeeps abreast of changes to PV Legislation and ensures Regulatory Intel is monitored for ZA and SSA territories.\u00a0
\n\tBasic PV training for all Aspen employees
\n\tContribute to the development of PV training.
\n\tPharmacovigilance training of all Aspen employees and distributors\/service providers and documentation thereof.
\n\tLiterature reviews
\n\tRegulatory review key Medical Journals for any adverse drug reaction reports with Aspen Pharmacare products\/medicines.
\n\tUnderstand SDEA obligations in order to ensure all aspects of the agreements are duly executed Facilitate SDEA training (to employees as well as 3rd parties).
\n\tSignal management
\n\tHighlighting any safety-related issues to the attention of the management team
\n\tCo-ordinate Safety Review meetings (monthly)
\n\tReview of Regulatory websites for any potential signals
\n\tAll other ad hoc PV activity duties as required by the business needs
\n\tAdhere to agreed Key Performance Indicators (KPIs).
\n\tSupport the continuous development and improvement of the PV function while upholding Aspen’s core values.
\n\tReceipt, evaluation, and reporting of individual case safety reports in accordance with international (export territories) and local regulatory requirements and contractual partner obligations.
\n\tProvide support to Global PV Global.<\/p>\n
CUSTOMER SERVICE<\/p>\n
\tAll queries are followed up and strictly within the policy framework, i.e., 48 48-hour turnaround time.
\n\tA professional attitude is displayed when responding to a customer\u2019s needs.
\n\tMethods for improving customer service are proposed.
\n\tInternal and external customers are kept updated, under supervision, as to the progress of their queries
\n\tLiaise on a daily basis with RA customers, i.e., SAHPRA, Marketing, Manufacturing sites, Quality-related departments, Public Health, Exports, Outsource, and relevant licensors and distributors.<\/p>\n
FINANCIAL<\/p>\n
\tIdentification of project challenges to departmental line management and the financial impact thereof<\/p>\n
GENERAL<\/p>\n
\tEnsure systems and procedures are in place in accordance with the RA QMS and that these are maintained according to the relevant SOPsAdhere to agreed Key Performance Indicators (KPIs)Support the continuous development and improvement of the PV function while upholding Aspen’s core valuesEffective management and utilization of resources to keep processes cost-effectiveCollating data for ad hoc requestsAdherence to Company Health & Safety proceduresParticipate in training programmesAny other duties assigned by your manager<\/p>\n
Requirements
\nEDUCATIONAL REQUIREMENTS<\/p>\n
\tBachelor’s or postgraduate degree in science, pharmacy, or medicine, or Post Basic Pharmacist Assistant<\/p>\n
KNOWLEDGE & EXPERIENCE REQUIREMENTS<\/p>\n
\tPV experience (2 years), experience in post-marketing reporting of AEs.Quality Assurance experience (1 year).GCP training is advantageous.Knowledge of relevant information sources, including printed publications, unpublished sources, databases, websites, social media sites, and external bodies.Effective understanding and use of the principles of information capture, storage, searching, and retrieval.Effective use of appropriate IT systems and programs.Understanding of relevant legal and related issues on copyright, codes of Practice, Data Protection legislation, regulations, and guidelines.<\/p>\n
SOFT SKILLS REQUIREMENTS<\/p>\n
\tBusiness process analysis
\n\tReport writing
\n\tInformation gathering and monitoring
\n\tProjects (advantage)
\n\tAbility to communicate information effectively and clearly in written form and orally, and at levels appropriate to the needs of different internal and external customers.
\n\tIntegrity
\n\tWork ethic
\n\tAbility to meet deadlines
\n\tPositive \u2018can\u2013do attitude\u2019
\n\tWork autonomously and have good problem-solving skills
\n\tAble to cope with evolving deadlines effectively, with regular feedback and updates
\n\tHonest and trustworthy
\n\tRespectful and highly personable
\n\tPossess cultural awareness and sensitivity
\n\tFlexible and confidentiality
\n\tPositive and proactive approach to business tasks
\n\tEnthusiasm and drive to take ownership and drive process initiatives<\/p>\n
Apply via company website ( ) or<\/p>\n
aspen.mcidirecthire.com<\/p>\n
<\/p>\n","protected":false},"author":2,"featured_media":0,"template":"","meta":{"_promoted":"","_job_location":"","_application":"http:\/\/aspen.mcidirecthire.com","_company_name":"Aspen Pharma Group","_company_website":"","_company_tagline":"","_company_twitter":"","_company_video":"","_filled":0,"_featured":0,"_remote_position":0,"_job_salary":"","_job_salary_currency":"","_job_salary_unit":""},"job_listing_region":[11],"job-types":[18],"class_list":["post-20305","job_listing","type-job_listing","status-expired","hentry","job_listing_region-gauteng","job-type-contract"],"jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/job-listings\/20305","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/job-listings"}],"about":[{"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/types\/job_listing"}],"author":[{"embeddable":true,"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/users\/2"}],"wp:attachment":[{"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/media?parent=20305"}],"wp:term":[{"taxonomy":"job_listing_region","embeddable":true,"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/job_listing_region?post=20305"},{"taxonomy":"job_listing_type","embeddable":true,"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/job-types?post=20305"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}