Lella B. Email & Phone Number

Woburn, Massachusetts, United States

• Developed and implemented audit program for Investigator Sites, Vendor and Internal Audits which met the regulatory requirement. o Coordinated 25 audits (ISA, Vendor, Systems) in the first 6 months after the audit program was launched.o Managed two vendor partners including.o Developed Vendor Qualification templates for CRO, IT, Laboratory and Vendor qualification.• Developed KPIs for upper management and executive leadership.• Worked closely with the cross-functional teams to close gaps and improve compliance and inspection readiness capabilities.

Woburn, Massachusetts, United States

• Supported five global clinical trials in Phase I or Phase I/II or Phase II as the primary clinical quality assurance contact.• Conducted review of clinical protocols, clinical study reports, investigator brochures and other clinical documentation against regulatory standards and for internal consistency.• Developed and implemented the Quality Event (QI) and CAPA process for Clinical Quality Assurance.• Worked with Project Managers, Department Managers on CAPA creation, investigation and implementation.

Boston, Massachusetts, United States

• Evaluated device adverse event reports and drug reactions to assess seriousness, expectedness, and relationship (France, Germany, Japan, Norway, Russia, UK, US).• Completed Reportability Assessments and Clinical Assessments in a timely manner with full adherence to company policies and procedures outlining complaint handling functions.

Boston, Ma

• Conducted internal audits for CRO following GCP standards in the following therapeutic areas: Oncology, CNS, Cardiovascular, and Musculoskeletal• Managed document control system • Conducted New Hire Training for all new employees (on-boarded over 50 employees)• Worked with Project Managers, Department Managers on CAPA creation, investigation and implementation.

Waltham, Ma

• Utilized in-depth knowledge of FDA and ICH guidelines and product labeling in managing the case management process in the ArisG system. o Zero late case initial and follow up submissions in a four-year period where the allegation of AE was reported before regulatory deadlines.o Performed initial potential AE / non-complaint triage review for approximately 5,000 events annually.o Performed monthly reconciliation between the ArisG system and PMS Complaint handling system.• Authored new and revised SOP and WI as needed.• Supervised three Pharmacovigilance data entry staff. • Served as subject matter expert and Pharmacovigilance Safety contact to other departments and Fresenius Medical Care-North America, Renal Therapies Group, LLC, and licensing partners. o Performed training for all corporate new hires on complaint and AE awareness as part of corporate on-boarding.o Developed and performed PV training for all PMS employees as part of new hire training and as an annual training course.• Supported regulatory and third-party PV audits and inspections as audit host, scribe, ran back room or SME depending on type of audit and audit supported required.

Waltham, Ma

• Performed first level triage for adverse events related to use of pharmacovigilance products.• Managed workflow to ensure timely ADE and FAR reporting, regulatory follow up, and closure of complaints in compliance within FDA and corporate guidelines• Participated in CAPA activities as required serving as owner and SME.• Supported FDA, ISO, and 3rd Party Audits as SME.

Waltham, Massachusetts, United States

• Collected information for investigation of complaint files by manufacturing plants.• Chaired weekly meetings between four manufacturing plants and corporate specialists to discuss open product complaints which reduced complaint cycle time by 15% while providing early potential issues requiring trend analysis.• Trained new and contract employees on products and complaint entry.• Reviewed complaints for a potential FAR and prepared Field Alert Report to submit to the FDA in accordance with regulations.

Waltham, Ma

• Acted as Compliance Wire Administrator• Executed verification of training document migration from Domino.doc to PTC Windchill.

Ba, History

Master Of Divinity (M.Div.), Honors