I possess over 30 years experience in medicine and over 20 years of Respiratory Therapy. I have a strong understanding from field medicine, to clinical, to pharmacological development and am adept at navigating high-pressure environments. I leveraged my expertise and compassionate nature to enhance safety protocols at Thermo Fisher / PPD, mentoring teams to exceed quality standards. My proficiency in data analysis and ability to quickly build rapport underpin my track record of driving success and positive outcomes.
I delivered the keynote speech for CPCC and CVCC graduation ceremonies and instructed numerous students on the entirety of Respiratory Therapy through Independence University while I served as the Clinical Educator at Caromont., resulting in two of our staff receiving their BS in respiratory therapy with no educational expense. I am an avid scuba enthusiast and my previous military experience has served me well with black water diving for evidence and recovery. I have always possessed a strong will to help others above all as I also served with the mobile hospital following Hurricane Katrina in Waveland, Mississippi.
Act as primary safety specialist for assigned projects. Attend Kick-off meeting present safety processing and related guidelines knowledgeably. Ensure projects are set up as per protocol, contract and proposal. Quality checking the activities, ensuring high quality data is produced. Set up regulatory processes, ensuring that regulatory reporting team have all necessary contact detail for safety reporting. Set up and maintain tracker for all assigned projects. Production of Project Specific Work instructions (PSWI). Ensure all instructions are detailed and documented appropriately within the SMMP and/or PSWI. Keep abreast with the status and metrics of assigned projects and communicate any issues to team manager in a timely manner. Quality Checking of Data in safety database, narratives produced by junior staff, case QC and closure, QC safety-related paper documents/electronic data/database entries prepared by others, QC of CIOMs. SAE Reconciliation - Review data management listings, database reports, and validation checks. Attend internal weekly project meetings and ERMs, client meetings, and other appropriate meetings, as required, for assigned projects to alert senior manager of potential issues relating to the project. Audit attendance - Prepare for and attend audit meeting. Produce and review quarterly, periodic and annual safety reports, ensuring these are submitted to appropriate authorities on time. Mentoring junior colleagues. Study close-out activities. Consistently demonstrates the ability to undertake responsibilities at the next level. Participate in Grand Rounds (therapeutic training) and internal training program. Kept up-to-date in safety regulations, processes, and PPD's policy regarding safety issues etc. Adhered to PPD's corporate policies, SOPs, WPDs, other guidance documents, sponsor SOPs/directives and project specific WPDs. Adhered to current global ICH/local guidelines regarding clinical trials, regulatory documents, and safety issues. Developed and maintained a co-operative working relationship with project team members. Developed supervisory and mentoring skills. Delivered presentation to clients, investigators, and project team members on safety. Arranged project specific training to the project team and if required liaised with medical affairs personnel to deliver therapy area training to the team. Performs lead duties much as KPIs, monthly reports, STS/Argus reconciliation, QE audits, and submission synopsis.
Performed day-to-day Pharmacovigilance (PVG) activities performed within a highly regulated environment and driven by strict timelines. Pharmacovigilance activities included but were not limited to collection, monitoring, assessment, evaluation, research and tracking of safety information. Coordinated and performed Pharmacovigilance activities such as data entry, coding and assessment of adverse events, case review, follow-up, tracking of reports, and regulatory reporting activities. Effectively collaborated with various parties such as: project team members, client contacts, investigators, and adverse event/ reporters, and third-party vendors. Assisted in
the preparation of departmental and project-specific procedures and processes, prepared for and attended audits, kick-off and investigator meetings. Participated in on-call duties for specific projects to ensure 24-hr coverage for intake of cases from investigative sites. Reviewed regulatory/pharmacovigilance publications and information sources to keep updated on current regulations, practices, procedures and proposals. Maintained medical understanding of applicable therapeutic area and disease states. Reviewed cases entered for quality, consistency and accuracy, including review of peer reports. Prepared and maintained regulatory safety reports. Assisted with routine project implementation and coordination (e.g., Clinical Trials, Endpoint Assessment Committee/Data Safety Monitoring Committee), including presentations at client/investigator meetings, and review of metrics and budget considerations. Mentored less experienced staff. Worked on problems of moderate scope where analysis of situations or data requires a review of a variety of factors. Developed professional expertise, applied company policies and procedures to resolve a variety of issues. Received general instructions on routine work, detailed instructions on new projects or assignments. Exercised judgment within defined procedures and practices to determine appropriate action. Contacts were primarily internal to the company with infrequent external customer / vendor contact on routine matters. Built productive internal / external working relationships.
Proficient in excel, word, PowerPoint, Argus, ArisG, electronic charting platforms
Highly dependable
Excellent attention to detail
Adaptive to a multitude of environments and pressures
Eager to learn
Fast learner
Wise
Builds rapport quickly
CRT
RRT
BLS
PADI
CRT
RRT
BLS
PADI