Experience

Agios Pharmaceuticals

• United States
• Pharmaceutical Manufacturing
• 300 - 400 Employee

• Senior Director, Head of Safety Operations

  • Oct 2021 - Present

• Director, Case Management/Safety Operations

  • Apr 2020 - Present

  Cambridge, Massachusetts, United States Accountable for the successful strategy, oversight, and execution of deliverables associated with case processing, expedited reporting and submission of designated aggregate safety reports. Ensures that safety information received from all sources are collected, managed and reported in compliance with company procedures, global regulatory requirements and guidelines. Responsible for case processing activities performed by vendors as well as internal staffing, processes, procedures, and… Show more Accountable for the successful strategy, oversight, and execution of deliverables associated with case processing, expedited reporting and submission of designated aggregate safety reports. Ensures that safety information received from all sources are collected, managed and reported in compliance with company procedures, global regulatory requirements and guidelines. Responsible for case processing activities performed by vendors as well as internal staffing, processes, procedures, and interdepartmental projects involving safety data captured in the global safety database. Serve as subject matter expert during inspections and internal audits. Collaborates within MSRM and with other company functional areas and cross-functional teams, and interacts with CROs, vendors, partners, and study teams on all aspects of safety data collection and reporting.



Takeda

• Japan
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Global Drug Safety Director, Case Processing

  • Jan 2019 - Mar 2020

  Cambridge, Massachusetts (Formerly Shire) Responsible for oversight of outsourced pharmacovigilance activities by a PV vendor. Ensure consistent quality and timeliness of case processing by the vendor in accordance with global regulations, Shire PV SOPs, guidelines and job aides. Responsible for ensuring vendor compliance with regulatory reporting, Shire standards and required training. Participate in the development of reporting rules and business processes to ensure compliance with regulatory reporting of individual… Show more (Formerly Shire) Responsible for oversight of outsourced pharmacovigilance activities by a PV vendor. Ensure consistent quality and timeliness of case processing by the vendor in accordance with global regulations, Shire PV SOPs, guidelines and job aides. Responsible for ensuring vendor compliance with regulatory reporting, Shire standards and required training. Participate in the development of reporting rules and business processes to ensure compliance with regulatory reporting of individual case safety reports, MDR and MDV. Provide input to safety database, EDC and reporting specifications. Act as subject matter expert on operations and oversight of safety case processing partners during audits/inspections as necessary. Coach staff in the appropriate application of clinical research conduct, laws, regulations, and standards, and compliance with applicable SOPs, quality procedures and policies. Develop and manage staffing plans and metrics including management of contracts and external resources. Participate in integration activities involving case processing and outsourcing to vendor(s). Participate or facilitate department meetings and vendor governance meetings. Show less



Shire

• Japan
• Biotechnology Research
• 700 & Above Employee

• Director, Head of Case Processing

  • Jun 2016 - Dec 2018

  Lexington, MA Responsible for oversight of outsourced pharmacovigilance activities by a PV vendor. Ensure consistent quality and timeliness of case processing by the vendor in accordance with global regulations, Shire PV SOPs, guidelines and job aides. Responsible for ensuring vendor compliance with regulatory reporting, Shire standards and required training. Participate in the development of reporting rules and business processes to ensure compliance with regulatory reporting of individual case safety… Show more Responsible for oversight of outsourced pharmacovigilance activities by a PV vendor. Ensure consistent quality and timeliness of case processing by the vendor in accordance with global regulations, Shire PV SOPs, guidelines and job aides. Responsible for ensuring vendor compliance with regulatory reporting, Shire standards and required training. Participate in the development of reporting rules and business processes to ensure compliance with regulatory reporting of individual case safety reports, MDR and MDV. Provide input to safety database, EDC and reporting specifications. Act as subject matter expert on operations and oversight of safety case processing partners during audits/inspections as necessary. Coach staff in the appropriate application of clinical research conduct, laws, regulations, and standards, and compliance with applicable SOPs, quality procedures and policies. Develop and manage staffing plans and metrics including management of contracts and external resources. Participate in integration activities involving case processing and outsourcing to vendor(s). Participate or facilitate department meetings and vendor governance meetings. Show less



Biogen

• United States
• Biotechnology Research
• 700 & Above Employee

• Senior Manager, Case Processing Oversight

  • Oct 2015 - Jun 2016

  Cambridge, MA Responsible for operational management and oversight of case processing activities performed both by SABR case processors as well as vendors (CROs) in Post-Marketing and Clinical Trial settings. Ensure safety case processing, in both the Post-Marketing and Clinical Trial settings, is in compliance with regulatory requirements, corporate and departmental procedures and data handling conventions. Maintain and verify execution of oversight plans for vendors (CROs) with case processing… Show more Responsible for operational management and oversight of case processing activities performed both by SABR case processors as well as vendors (CROs) in Post-Marketing and Clinical Trial settings. Ensure safety case processing, in both the Post-Marketing and Clinical Trial settings, is in compliance with regulatory requirements, corporate and departmental procedures and data handling conventions. Maintain and verify execution of oversight plans for vendors (CROs) with case processing responsibilities. Execute and monitor compliance and quality through review of monitoring reports and other oversight activities, ongoing assessment against KPI/OPI and ensure the implementation and effectiveness of Corrective and Preventive Action plans. Act as subject matter expert on operations and oversight of safety case processing partners during audits/inspections as necessary. Participate in the development and review of governing documents, such as SOPs, Safety Management Plans, and Safety Data Exchange Agreements. Liaise directly with partners and vendors and conduct partner oversight and performance management on contracted work.

• Senior Manager, Drug Safety

  • May 2013 - Oct 2015

  Cambridge, MA, USA Responsible for managing the development and implementation of processes necessary for day-to-day operations, and monitoring of the safety of the company’s marketed products through pharmacovigilance activities including intake, evaluation, processing, and follow-up of adverse event reports. Ensure timely and accurate reporting of Adverse Drug Experiences (ADE) and Adverse Drug Reactions (ADR) data to regulatory authorities, ethics committees and other bodies as required by regulations and in… Show more Responsible for managing the development and implementation of processes necessary for day-to-day operations, and monitoring of the safety of the company’s marketed products through pharmacovigilance activities including intake, evaluation, processing, and follow-up of adverse event reports. Ensure timely and accurate reporting of Adverse Drug Experiences (ADE) and Adverse Drug Reactions (ADR) data to regulatory authorities, ethics committees and other bodies as required by regulations and in accordance with company quality policies. Respond directly to inquiries from regulatory bodies and competent authorities. Participate in development of strategy and design as well as testing, validation, data migration and implementation of new global safety database. Develop, execute, review and approve corrective action plans stemming from internal and external audits. Participate in developing business rules for the review and identification of MDR/MDV for devices and combination products across R&D groups. Participate in global, cross-functional teams. Develop and manage staffing plans and metrics including proposals for contracts and external resources. Manage direct reports responsible for safety case processing and specialized safety case-related projects and functions and partnering with management colleagues to coordinate department efforts and direction.



Boston Scientific

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Safety Program Manager, Team Lead II

  • Apr 2011 - May 2013

  Marlborough, MA Manage a team of up to 18 Safety Trial Operations employees responsible for adverse event and medical device data processing and reporting. Participate in global, cross-functional teams across clinical operations. Manage vendors (CROs) for the Safety Trial Operations department across several business divisions. Liaise with clinical project managers and vendor counterparts to develop and communicate metrics, deliverables, issues and successes between vendor and study teams through the use of… Show more Manage a team of up to 18 Safety Trial Operations employees responsible for adverse event and medical device data processing and reporting. Participate in global, cross-functional teams across clinical operations. Manage vendors (CROs) for the Safety Trial Operations department across several business divisions. Liaise with clinical project managers and vendor counterparts to develop and communicate metrics, deliverables, issues and successes between vendor and study teams through the use of key performance indicators and service level agreements. Ensure accuracy and timeliness of the reportability of adverse events and/or medical device data to regulatory agencies and internal complaint management groups. Participate in the design and execution of SOPs, Guidelines and/or Work Instructions that meet the laws, regulations, and guidance governing adverse event processing and reporting for global clinical studies. Participate in the development of reporting rules and business processes to ensure compliance with regulatory reporting of MDR/MDV. Provide input to safety database, EDC and reporting specifications and assist in development of standards across the clinical team. Review and approve corrective action plans stemming from internal/external audits. Coach staff in the appropriate application of clinical research conduct, laws, regulations, and standards, and compliance with applicable SOPs, quality procedures and policies. Develop and manage staffing plans and metrics including management of contracts and external resources.

• Safety Line Manager

  • Mar 2008 - Apr 2011

  Manage 8-17 direct reports across therapeutic areas, functions, divisions, and/or regions. Provide year-round timely feedback, year-end reviews, support of professional development, mentoring, guidance, responsible for staff training to support career growth and development. Ensures that the safety plans of clinical trials are executed in accordance with corporate clinical and regulatory policies and procedures. Manage staff to appropriate and timely completion of program/project deliverables… Show more Manage 8-17 direct reports across therapeutic areas, functions, divisions, and/or regions. Provide year-round timely feedback, year-end reviews, support of professional development, mentoring, guidance, responsible for staff training to support career growth and development. Ensures that the safety plans of clinical trials are executed in accordance with corporate clinical and regulatory policies and procedures. Manage staff to appropriate and timely completion of program/project deliverables and timelines. Influences the development of policies and procedures across functions. Assists in development of department budget. Develops and executes operation staffing plans. Assignment of resources to clinical projects. Collaborates with clinical project teams members and functional area managers and acts as the BSC representative with external contacts as required. Concurrently working as Safety Trial Manager (see prior description).

• Safety Trial Manager

  • Jun 2007 - Apr 2011

  Supervise several Safety study teams and manage execution of project-specific Safety deliverables. Responsible for Safety-specific study start up activities, including creating Safety Plan, creating CEC adjudication forms, creating and reviewing edit checks for Safety data, user acceptance testing of study database, as well as review of protocol, DMP, CRF’s, CCG’s, Clinical Trial Complaint Reporting Plan and other cross-functional documents affecting Safety. Responsible for receiving and… Show more Supervise several Safety study teams and manage execution of project-specific Safety deliverables. Responsible for Safety-specific study start up activities, including creating Safety Plan, creating CEC adjudication forms, creating and reviewing edit checks for Safety data, user acceptance testing of study database, as well as review of protocol, DMP, CRF’s, CCG’s, Clinical Trial Complaint Reporting Plan and other cross-functional documents affecting Safety. Responsible for receiving and triaging and processing of ongoing site-reported Safety events, ensuring that event narratives are completed and adjudicated prior to study snapshots, reconciliation of EDC and Safety databases. Review of Safety data in annual clinical study reports to regulatory agencies, provide narratives for annual Safety reports to regulatory bodies.

• Sr. Medical Research Associate

  • Apr 2006 - Jun 2007

  Responsibilities include tracking adverse events, contacting sites and field clinical monitors to obtain required case report forms and source documents, writing event narratives and assembling event dossiers for events that are forwarded to a Clinical Events Committee for adjudication.

• Sr. Clinical Data Specialist

  • Feb 2004 - Apr 2006

  coordination of data management team activities, data management deliverables, study start up including defining database/edit check requirements, liaising with outside vendors and cross-functional study teams, quality control review, generation of queries, resolution of queries, and generation/QC of data listings to ensure compliance with protocols, FDA regulations and GCP guidelines



Sanofi

• France
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Contract Clinical Data Manager

  • Aug 2003 - Feb 2004

  Clinical Data Manager responsible for quality control review, generation of queries, resolution of queries and MedDRA coding.



Parexel

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Clinical Data Manager

  • Sep 2000 - Aug 2003

  Coordination of data management team activities, study start up including defining database/edit check requirements, liaising with study sponsors, outside vendors and cross-functional study teams, quality control review, generation of queries, resolution of queries, and generation/QC of data listings to ensure compliance with protocols, FDA regulations and GCP guidelines.



Reproductive Science Center of Boston

• Embryologist

  • 1993 - 2000