Babalwa Azakhiwe Nancy Mzileni

Manage case processing activities.

· Review, rank, verify, process and document case-related information: event terms; validity, seriousness, special scenarios; timelines; accuracy and consistency.

· Write and edit case narrative based on case assessment.

· Review processed cases to verify accuracy, consistency and compliance with process requirements, and review case data for special scenarios.

Monthly Reconciliations

· Liaise with key partners, locally, and other stakeholders regarding safety data collection and data reconciliation.

Regulatory guidelines and SOPs

· Develop and maintain expertise and knowledge for applicable corporate and global regulations, for guidelines, Standard Operating Procedures, for data entry conventions, and for search functions in the safety database.

· ICSR submission to Heath Authority, Ethics Committee and Principal investigators

· Determine reportability of scheduled reports, ensuring adherence to regulatory requirements.

· Consistently apply regulatory requirements and Pfizer policies ensuring adherence to requirements.

Participate, as appropriate, in local, internal and external safety activities

CAPA implementation

· Identifying non-compliance issues and implementing corrective and preventative actions

Medical journal/ Literature review

· Review medical journal published locally, monitor and screen for all the adverse events reported in that literature for ICSR processing

· Performing assessment of adverse event case reports

· Act 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

· Acts as a product owner for products under the remit of Pharmacare, supporting the PV Scientists with literature management and aggregate report preparation for their assigned products

· Responsible for providing a root cause analysis for any late reporting submissions

· Assisting with reconciliation of all adverse event reports received from PV service providers, affiliates, distributors and licence partners

· Contribute to the development of Pharmacovigilance training/ Pharmacovigilance training of all Aspen employees and distributors/service providers and documentation thereof.

· Support preparation of SOPs, WIs, product safety reviews as required

· Highlighting any safety related issues to the attention of the management team

· Keep abreast of changes to PV Legislation.

· Adhere to agreed Key Performance Indicators (KPIs)

· Support the continuous development and improvement of the Pharmacovigilance department while upholding Aspen core values. Receipt, evaluation and reporting of individual case safety reports in accordance with international (export territories) and local regulatory requirements and contractual partner obligations.

· Regulatory review key Medical Journals for any adverse drug reaction reports with Aspen Pharmacare products/Medicines.

· Perform pharmacovigilance checks of the Quality Assurance database

· Perform monthly or quarterly ADR reconciliation with cross-functional departments/ contractual partners/distributors

· Understand SDEA obligations to ensure all aspects under agreements are dully executed. Compilation and review of SDEAs.

· Signal management- Reviewing of Regulatory websites for any potential signals

· A general PI review of core products and products where molecules are under review. Also continuous review of innovator PI's in order to ensure update of our generic PI's in line with these.

· Management of Product Quality Complaints

· Complaint reconciliation with third parties and internal stakeholders

· Product Quality Reviews

· Contact third parties managed by the local country organization Track PQR review and sign off)

· Ordering of reference standards

· Post Importation Testing Exemption Applications to SAHPRA in consultation with Pharmacist/ CQH

· Compilation and reporting of distribution KPI's

· Maintenance of quality databases, Supply chain tracker, Quality Agreements and ensuring appendices are maintained and up to date.

· Change Control management: Tracking and management of change control from third party contract manufacturing

· Specifications: Create and update product specifications required for product release. Compile documents required for Product release, Sample dispatch to testing laboratory and track receipt Inspect the samples attributes prior to handover to Pharmacist. Match the incoming product sample with relevant CoA, packing list and invoice Downloading temperature data and action appropriate

· Management of the Master release tracker

Database management, Ensuring all tracking databases are up to date and maintained. Management of master documents in GEODE+ and Acts as a Document manager for all GxP functions, Screening for released global quality documents. Receive monthly quality document update. Receive monthly MCCQ quality document update. Summaries proposed changes in consultation with Pharmacist/ CQH. Works closely with the Pharmacovigilance team, exchanging PV data

· Provide high level administrative support in a dynamic and pressured environment in order to facilitate the smooth and effective running of the office of the Country Head of Medical

· Provide direct project support to the Medical Functions (medical governance, medical information, medical affairs, etc.)

· Management of the Basic Call Tracker

· Managing Incoming Medical Information Query calls

· Identifying and Rerouting Non Medinfo calls to different divisions e.g., Customer service, PV, QC and Pasture

· Management and oversight of contracts to be signed by Country Medical Head

· Ordering of articles from University

· Routine administrative support (meetings, meeting minutes, travel, accommodation, expenses, etc.) and specialized (medical databases & platforms) support to the medical department