Sofia Kline Email & Phone Number

Murrieta, Ca, Us

Amsterdam, Noord-Holland, Nl

•Participate in cross-functional clinical team(s) in the planning and execution of clinical trials. •Involved in site qualification, start-up activities including ICF review, budget, CTA, site monitoring, training and driving resolution of issues encountered with sites during all phases of the study.•Provide input and/or author study procedures, such as charters (CEC, DSMB), CIPs, ICF, IB, CTAs, NDAs, CRFs creation, and safety monitoring and management procedures.•Oversee day to day safety monitoring activities and safety ops of clinical trials for the assigned product(s).•Lead and collaborate with Complaints, Clinical Ops and Med Affairs teams to foster communication of potential safety concerns.*Lead process improvement initiatives and projects assigned by Head of Clin Ops & Med Affairs or identified by other internal departments that result in a CAPA or have the potential to result in a CAPA.•Contribute to aggregate safety reports such as CERs, CSRs to national and local competent authorities.•Assist in the preparation of response(s) to regulatory queries for safety information as required.•Assist on onboarding of CECs and DSMB members, including the processing and creation of related agreements.•Timely supervision of delegated monitoring activities to CRO, remotely and/or on-site, per the study monitoring plan/procedures.•Maintain an overview of new and modified SAEs, revascularizations, Core lab data and adjudication status. •Follow up with site or CRO on source docs collection, translation, filing and uploading on EDC database(s).•Review AE data to evaluate safety signals and follow-up with the clinical team, if needed.•Identify and assign events to CECs for assessment via EDC, process and approve consensus notifications. Set up and facilitate CEC meetings when appropriate.•SAEs narratives writing.•CAPA Investigator and VOE role. Point of contact for Safety/Post-Market related CAPAs. Support in risk management activities.

Carlsbad, California, Us

• Provide weekly updates on complaints metrics on daily standup meeting.• Create monthly trend report and present reports to management.• Support audits in backroom.• Assist in the review or Risk Assessment procedures.• Create and update DOPs and forms on regulatory reporting guidelines (domestic and internationally).• Create complaint reporting training material and perform training of new sales personnel.• Draft responses to domestic and international regulatory bodies’ inquiries.• Review and approve Complaint Investigation reports.• Receive, process, submit and closure of incoming complaints from beginning to end. • Receive, clean or decontaminate returned complaints products/devices. • Participate with other business units to improve processes to increase compliance with regulatory requirements.

Amsterdam, Noord-Holland, Nl

Primary contact for international customer experiences. Handling the complaint from receipt, to closure.• Led daily standup meetings on dept activities, metrics, backlog, and multiple ongoing projects.• Led special projects (such as Investigation of DEFOAs) and presented and explained data during management monthly meeting.• Participated in the QRB (Quarterly review Board meeting) representing the Complaints department.• Created and reviewed DOPs such as Domestic and International regulatory reporting guidelines, reportability matrix, application of HHE and Risk Assessment in Complaints.• Participated in internal and external audits (domestic and international) in the back room.• Assisted in department CAPAs, root cause analysis, performing investigation activities.• Trained and mentored new and current Complaint Analysts. Systems: TrackWise, SAP, Sales Force.• Participated with other Philips business units to improve reporting strategy and unify processes.• Drafted responses to requests for additional information from Domestic and International competent authorities.• Assisted in the creation and revision of DOPs for the Complaints Investigation Team, as well as provided assistance in the improvement of their investigation processes and documentation practices.• Processed domestic and international complaints. Drafted respective reports.

Irvine, Ca, Us

Primary contact for all customer experience reporting and adverse events handling activities related to Endologix products to comply with established regulations and provisions domestically –US 21 CFR Parts 803 & 820, and internationally, in geographies such as Canada, EU countries, Japan, AU/NZ and Latin America. • Reviewed and approved all department complaint files for completeness, accuracy, appropriate regulatory decision, appropriate device evaluation and closure. • SME and department mentor in regulatory reporting, reports drafting and data collection to respond inquiries. • Reviewed and approved Complaint Investigation analysis performed by the Complaint Investigation Engineers.• Created and revised company procedures related to regulatory reporting, domestic and internationally, to ensure that controls were in place to process all incidents in accordance with all applicable worldwide regulations and standards. • Supported FDA/NSAI/Gmed audits, and other notified bodies audits.• Drafted responses to letters from domestic and international regulatory agencies/bodies, with requests such as: additional case information, device evaluation, occurrence rates, risk assessment, product sales -worldwide and regional; between other inquiries.• Drafted evaluation reports/letters to physicians.• Performed Trend reports and collective analyses of product complaints and CAPAs.• Prepared reports for periodic management reviews developing customized data and assisting in the generation and monitoring of departmental metrics. • Responsible for receiving (via phone call, email, fax and Sales Force) of complaints worldwide for all product lines, regulatory assessment, customer follow-up.• Drafted and submitted reports (Initial and Supplementals) under domestic and international reporting regulations, ensuring timelines were met.

• Developed and revised departmental regulatory decision models, considering regulatory changes, as well as changes in product- advances/therapies to uphold consistent compliance with worldwide government mandated regulations.• Reviewed/updated the DOP of FDA coding, to help ensure consistency with FDA current guidelines, and to facilitate trending and data analysis.• Composed written communications detailing the clinical observation, investigation and/or product analysis, and corrective actions, as applicable, to physicians and other end use customers.

San Diego, Ca, Us

• Primary contact for domestic and international inquiries. Established effective working relationships with regulatory representatives (US and Canada). Prepared and submitted responses to those inquiries.• Owned regulatory reporting process for customer complaints (FDA, Health Canada) including preparation, review, submission and elevation of SAEs cases to management during weekly meetings. • Creation and procedure updates to accommodate regulatory changes. • Guided and assisted Complaints Investigation Team in daily activities, and DOP revisions to ensure investigatory requirements were met and in compliance with FDA requirements.• Led Complaints review weekly meetings with Engineering, Manufacturing, Research & Development, Quality, Legal and Operations teams. Additionally, I participated in multi-departmental teams to put in place Corrective/Preventive Actions and Risk Assessments updates. • Led the FDA project to incorporate electronic submission (eMDR) into departmental complaint process.

Abbott Park, Illinois, Us

• Led the department serving as Final reviewer and approver of all domestic and international reports (for two years). • Created and participated in the revision of multiple DOPs such as Global Reportability Guidelines on Literature Review, Worldwide Reportability Matrix, Regulatory Justification Paper for European Vigilance Exemptions due to Trending, and multiple Position Papers.• Interfaced with Corporate, Divisional and Site Regulatory, Quality, Engineering and consulting physicians to conduct risk assessments and determine reporting requirements. • Trainer of new Clinical or Regulatory Analysts during 2007 and 2008. • Received, analyzed and evaluated clinical and product data communication for FDA coding and assessment for regulatory compliance, reportability and potential impact to patient safety and business operations. Domestically and internationally: US/FDA, Europe (Vigilance), Canada, Australia/NZ, Japan, Brazil, between other Health Regulatory Authorities geographies.