•Provide global clients optimal business solutions and guidance based on industry experience, domain knowledge and best practices.
•Provide domain expertise to global clients during safety system implementation to automate or enhance business processes or configuration.
•Work with customers in establishing or enhancing their PV operations.
•Perform PV audits
•Author and/or update client's operational procedures including creative solutions for simplifying data entry conventions.
•Perform and consult on Argus Safety configuration/administrator tasks.
•Develop and conduct Argus Safety training.
•Handle all issues with relative ease by implementing best practices and applying critical thinking skills to find best solutions.
•Drive operational improvements which results in efficiencies and cost savings.
•PV staff augmentation
•Manage day-to-day operations of consulting business.

•Provide management oversight and mentoring to direct reports within Business Transformation practice.
•Facilitate resource management and assignment of Business Transformation members to projects.
•Provide pharmacovigilance (PV) consulting in organizational effectiveness, procedural development, process improvements and strategies based on regulations, best practice, and industry standard.
•Responsible for design of streamlined and harmonized PV processes for multiple small to midsize Biotech companies based on understanding current business processes.
•Led process system development/deployments with Argus Safety while adhering to internal and regulatory standards and developed/deployed in accordance to business expectations.
•Review and analyze various performance indicators to aid in optimizing/harmonizing business processes.
•Met with clients to understand needs and develop proactive solutions.
•Resolved pharmacovigilance operational problems, improved operations and provide

•Business Transformation Workstream lead on global projects.
•Provide management oversight to direct reports within Business Transformation practice.
•Provide pharmacovigilance consulting in organizational effectiveness, procedural development, process improvements and strategies.
•Responsible for design of streamlined and harmonized PV processes for multiple small to midsize Biotech companies based on understanding current business processes.
•Led process system development/deployments with Argus Safety while adhering to internal and regulatory standards and developed/deployed in accordance to business expectations.
•Review and analyze various performance indicators to aid in optimizing/harmonizing business processes.
•Review and analyze quality documents (i.e.
•Operating procedures, work instructions, etc.) for impacts as it related to system upgrade or implementation.
•Managed external stakeholders and led Business Transformation workshops.
•Work with Sales Team in providin

•Provide pharmacovigilance consulting in organizational effectiveness, procedural development, process improvements and strategies.
•Provide pharmacovigilance interim management support.
•Provide innovative solutions for safety systems and technology and assist in safety system implementations.
•Perform gap analysis for drug and device safety.
•Conduct quality audits according to Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP).

•Subject Matter Expert to IT Safety Platform team and customers based on pharmacovigilance experience.
•Managed relationship with external stakeholders.
•Collaborated with project team to ensure project timelines are met while maintaining quality.
•Directed business requirements gathering and documentation.
•Liaised with technical team to ensure understanding of requirements.
•Developed and drove business process efficiencies and standards across drug safety platform through stakeholder collaboration while assuring alignment with SOPs.
•Identified risk associated with project and develop mitigation strategies.
•Provided unique and innovative pharmacovigilance and safety system solutions to client business needs and issues.
•Led process system development/deployments adhered to internal and regulatory standards and developed/deployed in accordance to business expectations.
•Facilitated client workshops designed to identify customer requirements, drove pharmacovigilance and safe

•Subject Matter Expert to IT Safety Platform team and customers based on pharmacovigilance experience.
•Managed relationship with external stakeholders.
•Collaborated with project team to ensure project timelines are met while maintaining quality.
•Directed business requirements gathering and documentation.
•Liaised with technical team to ensure understanding of requirements.
•Developed and drove business process efficiencies and standards across drug safety platform through stakeholder collaboration while assuring alignment with SOPs.
•Identified risk associated with project and develop mitigation strategies.
•Provided unique and innovative pharmacovigilance and safety system solutions to client business needs and issues.
•Led process system development/deployments adhered to internal and regulatory standards and developed/deployed in accordance to business expectations.
•Facilitated client workshops designed to identify customer requirements, drove pharmacovigilance and safe

•Assisted with designing and planning work strategy of Pharmacovigilance Department.
•Provided management oversight and direction to senior and junior staff members.
•Implements Department work strategy through delegation, mentorship and supervision of staff.
•Provided oversight in project start-up for Pharmacovigilance and ongoing conduct of global services for new drug and/or device studies, provided guidance and mentorship to project Leads and direct reports.
•Communicated regular updates and promptly escalated any issues or concerns related to study conduct or staff performance to Executive management team.
•Intradepartmental representative in advisement for Regulatory and Clinical Operations services.
•Spear headed global transition process with regulatory for expedited safety reporting outside United States.
•Provided oversight, coordination and input for technical and training aspects of Pharmacovigilance Department.
•This involved migration of safety data to Argus 7.0 a

•Served as a global Pharmacovigilance Team Lead on multiple complex medium to large global projects.
•Provided leadership, mentoring and management for projects and pharmacovigilance staff.
•Ensured ICH and regulatory guidelines were adhered to in the safety process.
•Provided oversight of study budget, project quality and performed project-specific training.
•Managed multiple sponsors globally ensuring customer satisfaction, quality and consistency across protocols, financial and operational performance.
•Responsible for project related activities to include but not limited to face to face meetings, bid defenses, kick off meetings or start up activities, investigator meetings, audits team meetings and start up activities.
•Applied judgment, medical and clinical knowledge to analyze adverse events, assessing their completeness and accuracy.
•Interacted with investigative sites after the assessment to assist with accurate reporting of adverse events.
•Performed pharmacovigilance

•Coordinate and conduct inpatient or outpatient research studies for patients with congestive heart failure.
•Perform medical record review, data abstraction, and case report form completion studies involving heart failure.

•Co-owned a Legal Nurse Consulting business.
•Reviewed and thoroughly screened medical records for merit in potential medical malpractice and fraud cases.
•Located medical/nursing experts for attorneys.
•Assisted attorneys in preparing for depositions, arbitrations and trial.