David, MSc, RAQC (Hons)

• Lead vigilance regulatory compliance for medicinal products, medical devices, and cosmetics across the Septodont Group • Manage vigilance reconciliation activities with Septodont’s business partners • Develop and revise QMS documentation (SOPs, WIs, templates) to support streamlined regulatory compliance • Manage the creation and maintenance of global and local Pharmacovigilance System Master File (PSMFs) • Manage audits & inspection preparation; investigate deviation, non-conformities, and CAPA (Corrective Action Preventative Action) • Oversee qualification, training, and contract management for affiliates and service providers, including GDPR clauses, SDEAs, and technical agreements • Lead Vigilance System Set-up at the Affiliate level and coordinate with respective Qualified Persons for Pharmacovigilance (QPPVs) • Manage new-hiring training and mentorship Key Contributions:  Managed the renewal of 63 SDEAs and integrated updated templates into Agiloft, improving efficiency by ~15–20 mins per agreement  Resolved 95% of prior audit non-conformities through effective CAPA management  Brought the number of audit findings to zero for one of the most important service providers  Implemented process improvements for partner reconciliation, enhancing data quality & turnaround time  Supported global PSMF updates & led the successful set-up of PV systems across affiliates in UK, India, Australia, and Canada  Led end-to-end PV system implementation at the UK affiliate, including onboarding of UK QPPV/NCPV, development of SOPs/WIs, & staff training  Developed a global PV reportability matrix to support vigilance regulatory intelligence across the Septodont Group  Contributed to the management of Vigilance training to help train our Business Partners  Management of vigilance-related contracts in the Septodont Group contracts in Agiloft by liaising with the Legal Department  Coordinated inspection readiness activities for Health Canada, FDA, Swissmedic, and MDSAP

• Perform in continuous improvement of quality systems by developing work methods (SOPs/WIs), procedures, and standards for the workgroup • Perform the initiation, follow-up, and closure of reconciliations with partners (subsidiaries/affiliates, service providers, and distributors) • Preparation of monthly reconciliation with corporate vigilance and local reconciliation with QA for complaints • Supports the update/management of the global PSMF and other PSMF families • Timely publication of the vigilance metrics, KPIs and Annual Product Review reports • Assists in the management of distributors and partners on vigilance matters: o Maintaining currency of distributors and information relating to vigilance-related agreements and contracts and associated tracking tools. o Set up, revise, and maintain Safety Data Exchange Agreements (SDEAs) o Management of vigilance-related contracts in Septodont Group o Deliver training of distributors and vigilance partners o Follow-up of audit CAPAs and action plans within the perimeter of Vigilance • Assists in the management of Vigilance training according to the training plan • Supports vigilance regulatory intelligence activities of the Septodont Group • Preparation of vigilance reporting tools (IPV, dashboard. action plan, etc.) • Monitoring of vigilance KPIs • Organization of meetings and drafting of minutes • Archiving of vigilance-related documents and records (e.g. SDEA, training, reconciliation, etc.) • Maintenance of the global vigilance document-sharing platform with vigilance partners • Support vigilance audits/ inspections • Liaise with internal/external legal counsel and other internal groups as required • Follow GMP, GVP, GCP and regulatory requirements to ensure quality standards are met • Monitor Regulatory Intelligence to ensure Compliance within the Septodont Group

Key Contributions: • Handling compliance activities in the PV team such as safety audits and inspections, process improvement, assisting in updating SOPs, and creation of work instruction • SDEAs, PSURs, New Hire Vigilance training

Perform Pharmacovigilance (PV) activities for all Mint-marketed drug products in terms of ADR reporting, line-listings, CIOMS preparation, MedDRA, PV agreement with all vendors, PSUR compilation & submission to Health Canada, global literature screening, Canada Vigilance Database screening, maintenance of safety database, liaison with regulatory affairs team for any updated reference safety information on product monographs, retrieving sales data to assess patient exposure to drugs, work on change controls, deviation, CAPAs, change control processes, updating SOPs, and assisting in audits. Key Contributions: • Worked on process improvement and assisted in updating SOPs • Helped create checklists for each pharmacovigilance process to help with new-hire training

• Support in processing safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs), and product requirements. • Assist in pharmacovigilance activities for all Mint marketed drug products and API molecule levels including but not limited to, collecting, and tracking incoming Adverse Drug Reactions, product inquiries, and endpoint follow-up information. • Provide support in compiling data to prepare PSURs for all Mint drug products within the timeline required by Health Canada Guidance. • Perform literature searches and file search results as required by Health Canada. • Assist with Canada Vigilance database screening, filing, and ATIP request submissions. • Support completion of CIOMS forms and submission to Health Canada as per guidance. • Ensure to meet quality, productivity, and delivery standards per project requirements. • Ensure compliance to all marketed product-related processes and activities. • Recordkeeping. • 100% compliance towards all people practices and processes and record keeping. • Other administrative responsibilities and tasks as assigned.

Joined as a Customer Service Representative and then got promoted as a Team Lead managing a team of 10, collaborating new-hire training, involved in continuous process improvement, and ensuring the adherence of Standard Operating Procedures (SOPs) across all teams. Maintaining a positive, empathetic, and professional attitude towards customers at all times. Mentoring, and coaching to provide constructive feedback to the team members. Key Contributions: • Reviewing of training modules, enabling effective training objectives that resulted in an overall increase in the success rate of graduating candidates • Implementing well-established SMART (Specific, Measurable, Achievable, Relevant, and Time-Bound) goals to improve the team’s performance and quality

As Compliance Consultant, my roles and responsibilities were: - Create engaging eLearning modules to help employees to be compliant on corporate/regulatory compliance such as HIPPA (Health Insurance Portability and Accountability Act), Health and Safety, and other regulatory compliance - Creating informative presentations; presenting and delivering information to the clients at meetings, conferences, and Business Expos (even international)

Involved in the Post-marketing Surveillance of client-specific pharmaceutical drugs and medical devices. Tracking and reporting of Adverse Events (AE), Adverse Drug Reactions (ADR) or Serious Adverse Event (SAE), Special Situations, and Medical Device Complaints from patient’s medical records, clinical trial data, source documents, and audio-visual records to ensure that they are safe for patients by completing Periodic Safety Update Reports (PSURs). Accurately record and represent relevant information from medical and diagnostic reports and prepare concise narrative summaries of safety information. Working on various client projects in parallel and still meeting the deadlines with high quality. Key Contributions: • Performing quality review of the spontaneous cases (serious & non-serious cases), clinical studies, literature cases, recall cases before reporting to the client or regulatory authority abiding by the SOPs & timelines. • Working on Medical Dictionary for Regulatory Activities (MedDRA) coding, identifying & updating new ontologies from patient’s comments, and completing Safety Audits by reviewing Individual Case Study Reports (ICSRs) to comply with drug regulatory requirements.