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 Lead for the various Pharmacovigilance operations, in particular the medical and scientific functions with respect to safety evaluations of all Aspen products across Pharmacare and any other entity owned by Aspen, of the Aspen Group for which marketing authorizations are held. The role undertakes responsibility for coordinating and managing of review and analysis of aggregate safety data concerning the Aspen Group product portfolio.<\/p>\n
KEY RESPONSIBILITIES<\/p>\n
Key Accountabilities<\/p>\n
\tDelegated tasks from RA Manager or PV Lead on a defined and ad hoc basis with the flexibility of mindset and time resources this entails. This will include representation at meetings when required.
\n\tFunctional reporting: Mentoring of the Pharmacovigilance Officers and Medical Writers.
\n\tReview and advice regarding relevant local and global guidelines, policies, internal procedures, and SOPs across Aspen Pharmacare.
\n\tMaintain awareness of Pharmacovigilance regulatory requirements and developments.
\n\tManage outsourced data collection, organization, and preparation with vendors.
\n\tAct as Subject Matter Expert (SME) in designated areas (e.g., literature, signal management, aggregate reports, labelling, etc.), responsible for oversight and coordination of tasks related to the area of expertise.
\n\tPreparation of annual as well as ad-hoc and scheduled aggregate safety reports.
\n\tEnsure Good Documentation Practice.
\n\tContribute to agreed PV Team quality and compliance targets.
\n\tServe in a leadership capacity for complex and strategically important Pharmacovigilance developmental programs.
\n\tDirect interaction with Regulatory Authorities.<\/p>\n
Financial<\/p>\n
\t\u00a0Identification of project challenges to be escalated to the departmental line management and the financial impact thereof.
\n\tProject management of contractual and financial aspects of all medical writing projects and the effective utilization of resources to keep processes cost-effective.<\/p>\n
Medical Writing Accountabilities<\/p>\n
\t\u00a0Work in collaboration with Medical Writers to write clinical documents for submission to regulatory authorities, including but not limited to:
\n\tClinical overviews and summaries
\n\tIntegrated summaries of safety and efficacy
\n\tClinical Expert Statement
\n\tProvide medical editing review of draft and final documents prepared by other team members before internal or external distribution. This includes both copy editing and content review.
\n\tEnsure document content and style adhere to SAHPRA\/FDA\/EMA or other appropriate regulatory guidelines and comply with Aspen SOPs and style guidelines
\n\tPerform literature searches\/reviews as necessary to obtain background information and training for the development of documents.<\/p>\n
\u00a0Safety<\/p>\n
\t\u00a0ICSR (Individual Case Safety Reports)
\n\tEnsure all cases are processed, medical reviews completed, and cases submitted to Health Authorities as per the timelines specified in the guidelines.
\n\tEnsure quality checks are performed on weekly, monthly, quarterly, and bi-annual reconciliations with internal and external stakeholders.<\/p>\n
Labelling<\/p>\n
\tUpdating and reviewing Product Information in line with the Company Core Data Sheets, and other tasks as designated.
\n\tPreparation of aggregate safety reports, including but not limited to PSURs, PBRERs, and Addendum Safety Reports<\/p>\n
\u00a0Risk Management System<\/p>\n
\tPreparation of Risk Management Systems, including but not limited to Risk Management Plans and Risk Communication Plans.
\n\tRequest for Information (RFI) from Competent Regulatory Authority (CRA) and Safety Communication (Dear Healthcare Professional Letter (DHCPL)
\n\tManage safety-related requests from regulatory agencies and Aspen Affiliates to ensure any requests are answered fully and promptly.<\/p>\n
Literature Reviews<\/p>\n
\tMonitor local literature for designated products and identify safety issues\/ ICSRs in a timely manner.<\/p>\n
Signal detection<\/p>\n
\tCoordinate and prepare appropriately for signal management meetings.
\n\tSignal Management Activities, including compilation of Signal Assessment Reports\/ Case Series Reviews for potential signals.
\n\tCreation and update of Safety Data Exchange Agreements (SDEAs).<\/p>\n
Training<\/p>\n
\tOversee training and mentoring of other Pharmacovigilance staff, and prepare training materials
\n\tLead initiatives to develop, implement, and conduct appropriate training in all aspects of Pharmacovigilance Safety activities
\n\t\u00a0Maintain a high and up-to-date level of product and therapy area knowledge by attending conferences, training courses, and reading relevant medical and scientific literature<\/p>\n
QMS<\/p>\n
\tEnsure systems and procedures are in place in accordance with the RA QMS and that these are maintained according to the relevant SOPs
\n\tCreation and update of SOPs\/WIs for all pharmacovigilance activities related to the job role in line with Pharmacovigilance regulations\/guidelines (EU, ZA, and other territories applicable), within specified\/SOP timelines.\u00a0<\/p>\n
General<\/p>\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\tEffective management and utilization of resources to keep processes cost-effective
\n\t\u00a0Collating data for ad hoc requests
\n\tAdherence to Company Health & Safety Procedures
\n\tParticipate in training programmers and any other duties assigned by your Manager<\/p>\n
Requirements
\nEDUCATIONAL REQUIREMENTS<\/p>\n
\tBiological \/ life Sciences Degree or equivalent
\n\tB. Pharm would be advantageous<\/p>\n
KNOWLEDGE & EXPERIENCE REQUIREMENTS<\/p>\n
\tDocumented experience in all aspects of pharmacovigilance is an inherent requirement and not negotiable
\n\t3-5 yrs. Pharmaceutical experience with a specific focus areas in PV\/Drug Safety
\n\tExperience working with safety databases
\n\tExperience writing large safety reports, e.g., DSURs, PADERs, PSURs, PRBRERs, is preferable
\n\tExperience in writing RMPs is desirable
\n\tExperience working with the MedDRA coding dictionary
\n\tStrong knowledge of regulatory and medical authorities in South Africa
\n\tStrong understanding of regulations, ICH guidelines, and GCP
\n\tExtensive medical writing and expertise in submission<\/p>\n
SOFT SKILLS REQUIREMENTS<\/p>\n
\tResults and performance driven
\n\tStrong work ethic and integrity
\n\tAbility to meet deadlines
\n\tSense of urgency \u2013 responding to issues and opportunities in a timely manner
\n\tIntellectual curiosity \u2013 willing to suggest and try new ideas
\n\tPositive and proactive approach to business tasks
\n\tExcellent interpersonal and communication skills
\n\tA solutions provider
\n\tManage evolving deadlines effectively with regular feedback and updates
\n\tEnthusiasm and drive to take ownership and drive process initiatives
\n\tService orientation
\n\tCustomer-focused
\n\tLogical thinking
\n\tInformation seeking
\n\tPositive \u2018can\u2013do\u2019 attitude
\n\tBe able to work autonomously and have good problem-solving skills
\n\tAble to cope with evolving deadlines effectively, with regular feedback and updates
\n\tRespectful and highly personable
\n\tPossess cultural awareness and sensitivity
\n\tFlexibility & confidentiality are key requirements for this role.<\/p>\n
go to method of application \u00bb<\/p>\n
Apply via company website ( ) or<\/p>\n
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