Mary Holowenko

Trial Lead responsible for SAE case processing from case reception to closure and eTMF filing, SAE reconciliation, TPO oversight, and safety reporting (SUSARs, bi-annual reports, DSURs) including distribution. Responsible for database setup, development of safety management plans and work instructions, development, and testing of SAE reconciliation tools. Collaborate and communicate with sites, CRAs and other departments to ensure safety events are accurately reported, monitored and follow-up on.

• Processed Serious Adverse Event (SAE) cases and entered data into ARGUS safety database • Drafted safety narratives in ARGUS based on company templates • Assisted in retrieving and generating safety data outputs and producing listings from the safety database for preparation of aggregate safety reports (including DSUR) • Collaborated with other departments on patient narratives and clinical study reports • Performed SAE reconciliation between clinical and safety databases • Filed safety documentation on the TMF

• Activated Sites for Oncology Clinical Trials according to agreed timelines and quality standards • Liaised with Site staff, CRAs and TRIO team members to ensure timelines were met • Reviewed and approved documents required for site activation including country/site level informed consent forms, contract and budget negotiations • Managed logistics of study drugs, materials, equipment, documents and system access for Sites • Negotiated budget amendments with Investigators/Sites and approved payments • Obtained, reviewed and approved regulatory documentation; filed documents on the TMF • Provided monitoring support and reviewed/approved monitoring reports

• Managed/reviewed SAE reports and transmitted to sponsors; performed AERS data entry • Reviewed data listings and performed SAE reconciliation between clinical and safety databases • Wrote, reviewed and quality checked case narratives; prepared CIOMS/MedWatch reports • Distributed SUSAR/Safety Notifications to Principal Investigators and Sites • Wrote and distributed pharmacovigilance reports to stakeholders (including DSUR) • Liaised with Project and Data Management, Sites and CRAs to follow-up on adverse events

• Reviewed and processed SAE Reports and Data Clarification Forms in a timely manner in compliance with GCPs, country-specific regulations, and study protocols/guidelines • Prepared and quality checked clinical patient narratives, detailing adverse events for the sponsor • Validated safety data from clinical studies and quality checked paper and electronic files • Reconciled Serious Adverse Events between safety and clinical databases • Assisted with preparing Safety reports and Clinical Study reports • Performed QC/ review of Sponsor Study File and departmental documents to ensure compliance • Reviewed User Acceptance Testing of CRF study setup and reports for completeness

• Coordinated department projects for software, hardware, server and equipment upgrades including budgeting, ordering, planning, execution, documentation, training and implementation • Designed, executed and technically reviewed documents for equipment qualifications and commissioning, method transfers and validations, software and systems validations • Managed the Reference Standard and Retained Samples Programs • Managed the Metrology function for calibration/maintenance and vendor service agreements *Coordinated ChemStation Plus (ChemStore) software/server/equipment upgrade for QC resulting in continued product support and 21 CFR Part 11 compliance with minimal down-time. *Installed and validated new instrument calibration and maintenance software and database – ProCalV5 for MS SQL Server - providing a functional compliant tool with increased accessibility for scheduling activities and reporting results. *Chosen to coordinate the on-site Metrology function to oversee equipment maintenance, calibration and service agreements; successfully secured a transition from in-house to outsourced services which resulted in cost savings. *Supervised installation and validation of an online continuous temperature monitoring and mapping system allowing for 24/7 recording of data without cumbersome equipment.

• Qualified and commissioned new equipment • Coordinated method transfers and validation protocols • Assisted analysts with training and troubleshooting of methods and equipment • Managed the Reference Standard Program • Ensured compliance for compendial methods *Optimized the in-house coulometric Karl Fischer moisture method; modified procedure and equipment as required leading to successful validation of the method. *Equipped and commissioned a cGMP compliant Quality Control Sampling Room with dedicated space to ensure product quality and integrity during sampling events.

• Audited labs and reviewed equipment logbooks ensuring compliance with procedures/regulations • Technically reviewed analytical results against specifications and procedures • Managed the Reference Standard Program • Tested samples against specifications; executed and documented analyses and protocols according to cGMP • Assisted analysts with assay training and troubleshooting *Instituted a Reference Standard Program to guarantee qualification and inventory management. *Increased testing capabilities by successfully transferring in numerous new product test methods.