Expert Details

Expert in Pharmacovigilance

Expert ID: 735261 Massachusetts, USA

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Pharmacovigilance professional with 18 years’ experience developing and reengineering PV departments in small to medium sized pharmaceutical/biotechnology companies. Operational expertise includes the evaluation, development and implementation of PV processes and infrastructure, vendor management, SOP development and revision, CAPA management, compliance management and audit/inspection readiness. Expertise in the evaluation, analysis and strategic vision of PV Operations scalable to the current and future needs of the organization. This includes the selection, design, implementation, upgrade and data migration of safety databases (Argus, ARISg) as well as the management of global Safety activities for clinical trial and commercialization requirements within the USA, Canada, Japan and the EMA. Successful preparation and execution of Regulatory Authority inspections include those from the FDA, EMA, MHRA and Health Canada along with various QPPV audits.

Numerous gap analyses and vendor audits conducted. Extensive experience with clinical trial and post marketing data analysis as well as the development of Investigator Brochures, SMPs, PVMPs, DSURs, PADERs, PSURs, RMPs, Informed Consents, protocol development (safety sections), ISS and PBRERs.

Computer Skills: Argus-PVQ, ARISg, ClinTrace (Empirica Trace), Adobe, RAVE, jReview, MS Office, MedDRA Browser

Education

Year Degree Subject Institution
Year: 2000 Degree: Masters Subject: Business Administration Institution: Suffolk University Frank Sawyer School of Management-Boston, MA
Year: 1993 Degree: Bachelor of Science Subject: Nursing Institution: Dalhousie University-Nova Scotia, Canada
Year: 1990 Degree: Diploma of Nursing Subject: Diploma of Nursing (Registered Nurse) Institution: Prince Edward Island School of Nursing-Prince Edward Island, Canada

Work History

Years Employer Title Department Responsibilities
Years: 2018 to Present Employer: Undisclosed Title: Pharmacovigilance Consultant Department: Responsibilities: Senior Pharmacovigilance Consultant
• Provided Project Management expertise for the PSMF cross functional team
• Developed sections of the PSMF based on GVP requirements
• Lead the safety database RFP process providing strategic and project management expertise
• Development SOPs required as part of the PSMF development
• Worked collaboratively with Alder personnel as well as the external QPPV

QA Consultant
• Lead auditor conducting vendor audits conducted on behalf of industry leading clients
Years: 2018 to 2018 Employer: Sage Therapeutics, Inc. Title: Senior Director Pharmacovigilance Operations Department: Therapeutic Area: Postpartum depression Responsibilities: ● Provided strategic planning, implementation, and management of DSPV Operations activities in preparation for US product launch.
● Provided strategic input on the PV Operations department build out.
● Responsible for managing internal and external staff allocated to operational DSPV activities, creating a highly efficient team across insourced and outsourced resources.
● Provided expert guidance and leadership both internally and externally based on in-depth knowledge of development and post-marketing safety requirements, per ICH; US and international regulations and guidelines; and Good Pharmacovigilance Practice (GPvP).
● Builds and implements pharmacovigilance systems fully compliant with the applicable worldwide Health Authority PV regulations.
● Ensures that the DSPV Argus Database supports the department needs, including specific workflows and reporting/querying functionalities. Provides oversight of systems and MedDRA updates in collaboration with the relevant DSPV vendor.
● Lead the RFP process for vendor selection to support an outsourced DSPV business model.
● Provided vendor oversight and management for all outsourced or insourced PV activities, including establishing and monitoring key quality and compliance metrics.
● Collaborated with QA to develop a process for the identification and exchange of Product Complaints.
● Developed and implemented an inspection readiness program with the contribution of other DSPV and non-PV stakeholders.
● Lead the initiative to reevaluate existing SOPs and determine what updates or new SOPs are needed to be compliant with global regulations.
Years: 2017 to 2018 Employer: Self Employed Title: Pharmacovigilance Consultant Department: Responsibilities: Consultant (Project based)
Compliance, Training and Strategic Alliance (Sunovion)
Safety and Benefit Risk (SABR): Senior Pharmacovigilance Consultant (Biogen)
Head of Pharmacovigilance Operations: Pharmacovigilance Consultant (Ironwood)
Years: 2016 to 2017 Employer: Tesaro-Waltham, MA: USA Title: Head of Pharmacovigilance Operations Department: Therapeutic Area: Oncology Responsibilities: ● Provided strategic and tactical approach to the management and oversight of the company’s drug safety process for both investigational and marketed products in compliance with internal SOPs and with domestic and worldwide regulations (ICH) and guidelines in preparation for product launches in the USA and EU.
● Participated in the NDA and MAA for Zejula and Varubi by providing safety data, developing regulatory authority safety sections and providing PV review.
● Participated in providing safety responses for regulatory authority questions.
● Provided strategic planning, implementation, and management of PV Operations activities in preparation for US and EU product launch.
● Lead the initiative for RFP vendor selection and data migration.
● Collaborated with QA to develop a process for the identification and exchange of Product Complaints.
● Participated in the development and analysis of aggregate reports (RMP, DSUR, PSUR)
● Worked closely with the QPPV in the development of the Pharmacovigilance System Master File (PSMF) and provided strategic input on regulatory strategy.
● Organized and provided oversight to the receipt, evaluation, processing, documentation, and reporting of adverse event information from clinical trials, investigator trials and/or post-marketing sources for both Argus and ARISg.
● Developed and implemented SOPs, PVAs, SMPs and other documents to support investigational and marketed product safety surveillance.
● Managed and conducted ongoing safety surveillance on company products.
● Prepared new drug application safety updates, investigational new drug safety reports, investigator communications, Periodic Safety Update Reports (PSURs) and product labeling/package inserts and other reports as needed.
● Participated on cross-functional product/project teams including review of safety section of protocols, investigator brochures, marketing documents and other documents providing safety content.
● Developed and implemented Pharmacovigilance training programs for both internal and external use.
● Liaised with Clinical Operations, Regulatory Affairs and Quality to ensure appropriate and timely communication/dissemination of safety information to internal members and external stakeholders.
● Prepared for regulatory inspections and audits.
● Served as a key functional interface for drug safety regulatory inspections and audits, together with regulatory affairs and Quality Assurance and any corrective action plans.
Years: 2011 to 2016 Employer: AMAG Pharmaceuticals, Inc.-Waltham, MA: USA Title: Director/ Associate Director Department: Responsibilities: Director Global Pharmacovigilance Operations: 2014- 2016
Associate Director Global Safety Operations: 2011- 2013
● Responsible for overseeing the company’s Adverse Event Global Information System, Pharmacovigilance Standard Operating Procedures, and Pharmacovigilance compliance activities.
● Ensured the Adverse Event Global Information System met user needs and regulatory and quality requirements worldwide (ICH, FDA, EMA).
● Established partnership arrangements with the Argus safety database vendor IT support and key vendors and project consultants or delegate as appropriate.
● Responsible for Inspection/Audit readiness.
● Project management of pharmacovigilance deliverables including but not limited to periodic reports, signal detection, health authority responses, quality/product complaint responses.
● Participated in the development and review of ISS, PSUR, DSUR, annual reports and other aggregate reports as needed.
● Managed SDEA with business partner including RMP development and review.
● Performed coding review and developed safety narratives for clinical study reports.
● Collaborated with the Vice President of PVPE to establish and implement efficient procedures to optimize Global Drug Safety/Pharmacovigilance operations for safety reporting and regulatory compliance.
● Evaluated, modified and /or created efficient internal processes to assure regulatory compliance for global drug safety function across clinical trials and post marketing activities.
● Maintained process flow and implement process changes to assure continued regulatory compliance as needed.
● Acted as primary point of contact for FDA/EMA/MHRA/Health Canada safety audit/issues.
● Provided Drug Safety operations, guidance and expertise to address the specific needs of in-licensing and out-licensing agreements ensuring timely foreign and domestic regulatory obligations are met.
● Responsible for the oversight of compliance elements of PV such as management of CAPA, Audit/Inspection readiness and management of key performance indicators.
● Managed post-marketing requirements within the USA, Canada and other regions with business partner.
• Participated in the development and analysis of aggregate reports (Investigator Brochure, DSUR)
Years: 2013 to 2014 Employer: EMD Serono, Inc.-Billerica, MA: USA Title: Associate Director Global Drug Safety Advisor: Operations Department: Therapeutic Areas: MS, Infertility, Oncology Responsibilities: Provided input into process revision and integration based on LEAN.
● Contributed to effective proactive safety strategies for the assigned product(s) including the risk management and benefit-risk evaluation for the product.
● Performed signal detection from the internal safety database and FDA´s AERS database, and literature reports.
● Provided safety input to clinical trial activities as appropriate.
● Authored safety sections of trial related documents (e.g. protocol, informed consent, case report form, SAE form, monitoring plan, Interactive Voice Response System specifications, SAE reconciliation plan, study report) and coordinate review of/contribution to these documents by relevant PV functions where applicable. Wrote the program specific/trial specific Drug Safety Manual.
● Reviewed documents related to outsourcing of trials (e.g. CRO contracts, Request For Proposals and Service Agreements with CROs).
● Interfaced with internal and external Departments/Functions as well as Regulatory Agencies, Consulting experts, members of IDMCs/DSMBs and co-development partners as appropriate.
• Participated in the development of several RMPs
Years: 2009 to 2011 Employer: Synta Pharmaceuticals – Lexington, MA: USA Title: Associate Director, Drug Safety Department: Therapeutic Area: Oncology Responsibilities: ● Acted as the point of contact for all safety reports and reporting requirements in collaboration with medical officers, regulatory affairs and clinical operations.
● Responsible for the intake, review, evaluation, processing, reporting of relevant SAE reports from clinical trials and performs QC of serious adverse events reports during case processing.
● Prepared and reviewed periodic safety reports (PSUR, EU Annual Safety Reports) in accordance with regulatory requirements (ICH, FDA) and standard operating procedures.
● Coordinated safety activities between internal and external partners.
● Supported medical review of spontaneous case reports and Serious Adverse Event reports from clinical trials, according to SOPs and guidelines.
● Provided review of clinical protocols and study reports to ensure safety data are adequately addressed.
● Participated in the NDA by providing safety data, developing regulatory authority safety sections and providing PV review.
● Participated in providing safety responses for regulatory authority questions.
● Managed CRO operational activities related to Drug Safety.
● Identified and developed key SOPs/Work Instructions for the department.
● Assisted in the development of study-related documents including: protocols, CRFs, and Investigator Brochures.
● Prepared, organized and delivered Drug Safety presentations at investigator meetings
● Provided safety review of individual and aggregate clinical data.
● Worked closely with QA to ensure GCP compliance for all Drug Safety activities.
Years: 2005 to 2009 Employer: Antigenics, Inc. (Agenus Inc. ) Lexington, MA: USA Title: Drug Safety Manager Department: Responsibilities: Therapeutic Areas: Oncology (NDA), Infectious Diseases
Years: 2002 to 2005 Employer: The Harvard Clinical Research Institute - Boston, MA: USA Title: Various Department: Responsibilities: Manager of Clinical Safety: 2003-2005
Clinical Safety Associate I: 2002-2003
Therapeutic Area: Cardiology
Direct Reports=5

Career Accomplishments

Associations / Societies
Associations: Drug Information Association (DIA), Beta Gamma Sigma, Drug Safety Executive Council (DSEC)
Licenses / Certifications
Certifications: MedDRA: Maintenance and Support Services Organization (MSSO)
● Interpreting Data and Query Development, Advanced Coding: Coding Conventions and the MedDRA “Points to Consider Document”, Coding with MedDRA, MedDRA Essentials, MedDRA for the IT Professional

Licenses: Registered Nurse- Massachusetts, USA

Fields of Expertise

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