REBECCA NOLAN OLSON
Encinitas,CA
Summary
Results-driven and efficient operational professional with extensive industry experience in safety surveillance, data management, and working with Argus and Medidata (RAVE) EDC and pharmacovigilance systems. Proven track record of success across various indications, including oncology, hepatic diseases, neuro-muscular diseases, SMA, ophthalmology, and cardiovascular diseases. Recognized as an innovative leader and clear communicator skilled in safety case processing, SUSAR regulatory reporting, and aggregate reporting. Strong relationship-building with peers and clients is a key strength.
Overview
10
10
years of professional experience
Work History
SAFETY MANAGER
Oncternal Therapeutics
01.2024 - 09.2024
- Oversaw and maintained safety integrity by reviewing CRO safety data base collection and data output, including TLFs, design of output for presentations/papers, and regulatory filings (TEAE/TRAE tables, updates of safety information for IB, DSUR, CSR, etc)
- Evaluated clinical trial events to identify a potential safety issue and ensure best response
- Triaged, escalated, and organized newly identified potential safety issues for further evaluation
- Provided pharmacovigilance expertise to support compilation and organization of responses to safety inquiries from internal stakeholders, Food and Drug Administration, or global competent authorities and regulators
- Collaborated and provided expertise and knowledge for potential new products, clinical studies, technical file remediation, and change development
- Provided safety input to risk management
- Participated in development and maintenance of Medical Safety processes and Standard Operating Procedures
- Acted as primary safety contact for CROs
- Reviewed and ensured SAE/SUSAR reporting occurred in a timely manner
MANAGER (PV Operations)
Intercept Pharmaceuticals
03.2022 - 12.2023
- Reviewed reported adverse events (AEs) and potential safety issues across pre-and post-marketing sources
- Ensured safety reports were booked, triaged, evaluated, followed-up and closed per departmental procedures
- Assisted with drafting of analysis of similar events for Suspected, Unexpected, Serious Adverse Reaction (SUSAR) reports and ensured uniform and timely processing of safety reports
- Assisted with preparation of aggregate safety reports and/or line listings such as the Development Safety Update Report, periodic line listings, ad-hoc analyses, etc
- Provided oversight of vendors, contracted service providers, and corporate partners to ensure compliance with contracts and agreements related to safety reports case processing and reporting, SAE reconciliation, vendor reconciliations, submission compliance, and case QC, and case closure activities
- Represented PV operations team in study team, cross-functional, and investigator meetings
- Developed and maintained department SOPs, Work Instructions (WI), and other procedural documents
- Maintained departmental and pharmacovigilance documentation in an audit-ready state and supported audits/inspections and participated in process improvement plans for streamlining PV Ops activities
- Trained junior members of PV Ops team
- Maintained ongoing knowledge of most current global PV-related regulations
SENIOR ASSOCIATE (Clinical Safety Operations)
Intercept Pharmaceuticals
12.2019 - 03.2022
- Reviewed and assessed site reported adverse events (AEs) and other clinical trial data for potential safety issues
- Ensured uniform and timely processing and reporting of safety reports in accordance with SOPs and worldwide regulatory authority regulations
- Assisted with preparation of aggregate safety reports such as the Development Safety Updates Reports, periodic line listings, ad-hoc analyses, etc
- Collaborated with vendors, contracted service providers, and corporate partners to ensure compliance with contracts and agreements related to safety case processing and reporting
- Oversaw outsourced activities associated with case processing such as SAE reconciliations, vendor reconciliations, submission compliance, and case QC, and case closure activities
- Assisted with development and maintenance of PV plans including safety management plans, regulatory reporting plans, and SAE reconciliation
- Developed and maintained department SOPs and other procedural documents
- Effectively managed multiple competing priorities while maintaining focus on delivering exceptional results for clients and the organization.
DRUG SAFETY SPECIALIST
Halozyme Therapeutics
04.2019 - 11.2019
- Assisted in various areas of safety management and provided support on various partner programs
- Aided in development of work instructions and guidelines, provided oversight of vendor Contract Research Organizations, and conducted expedited case reporting
- Evaluated safety case data with an emphasis on medical presentation, conducts discussions on specific patient case data with health care practitioners, Sponsors, and business partners, determining regulatory reporting requirements based on case data, product information, and FDA or ICH guidelines and regulations
- Prepared safety reports, including preparation of narrative summary, and generation of reports for submission to Competent Authorities and reconciled safety data with applicable sources
- Identified missing/discrepant data (medical and documentation issues), wrote queries, addressed queries, evaluated query responses, and resolved queries when complete
SENIOR SAFETY SURVEILLANCE ASSOCIATE
Synteract
10.2015 - 04.2019
- Discussed safety project needs with clients, performed project start up and close out activities, and represented safety on the project team
- Reviewed and analyzed safety report information for completeness, accuracy and regulatory reportability requirements
- Evaluated safety case data with an emphasis on medical presentation, conducted discussions regarding specific patient case data with health care practitioners, Sponsors, and business partners and determined regulatory reporting requirements based upon case data, product information, and FDA or ICH guidelines
- Prepared safety reports, including preparation of narrative summary, and generation of reports for submission to Competent Authorities and identified missing data, wrote queries, addressed queries with site personnel and/or reporter, evaluated query responses, and resolved queries when complete
- Determined configuration specifications for the safety database, including updates
SAFETY ASSOCIATE II
SynteractHCR
06.2014 - 10.2015
- Reviewed and analyzed safety report information for completeness, accuracy and regulatory reportability requirements
- Prepared safety reports, including preparation of narrative summary
- Evaluated safety case data with an emphasis on medical presentation; conducted discussions regarding specific patient case data with health care practitioners and Sponsors
- Identified missing/discrepant data (medical and documentation issues), wrote queries, addressed queries with site personnel, evaluated query responses, and resolved queries when complete
- Performed coding of adverse event and medical history terms, concomitant medications, and laboratory test names within the safety database
- Reconciled safety data with applicable sources
Education
Bachelor of Arts (B.A.) - Art History and Criticism
University of California
San Diego, CASkills
- Clinical Research and Trials
- Clinical Data Management
- CRO
- GCP
- EDC
- Biotechnology
- Drug Safety
- Safety Operations
- Project Management
- Team Leadership
- Pharmaceuticals
- SOP
- Client Relationships
- Communications
- Regulatory Reporting
- Safety Management Plan
- Analytical Thinking
- Safety Program Development
- Implementing policies
- Inspections
Additionalrelevantexperience
- Safety Surveillance Associate I, SynteractHCR, Carlsbad, CA
- Clinical Data Manager, SynteractHCR, Carlsbad, CA
- Clinical Data Coordinator, SynteractHCR, Carlsbad, CA
Timeline
SAFETY MANAGER
Oncternal Therapeutics
01.2024 - 09.2024
MANAGER (PV Operations)
Intercept Pharmaceuticals
03.2022 - 12.2023
SENIOR ASSOCIATE (Clinical Safety Operations)
Intercept Pharmaceuticals
12.2019 - 03.2022
DRUG SAFETY SPECIALIST
Halozyme Therapeutics
04.2019 - 11.2019
SENIOR SAFETY SURVEILLANCE ASSOCIATE
Synteract
10.2015 - 04.2019
SAFETY ASSOCIATE II
SynteractHCR
06.2014 - 10.2015
Bachelor of Arts (B.A.) - Art History and Criticism
University of California
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