Cinderella Lessman

Pharmacovigilance / Medical Safety/Medical Reviewer

RAPID MEDICAL RESEARCH/QUANTUM 1 MEDICAL RESEARCH

Fort Collins, CO

03.2005 - 10.2023

Conducted medical review of individual cases and collective data for the assigned product(s)
Offered safety guidance for various clinical and regulatory tasks such as preparing Investigator's Brochures, study protocols, study reports, and product registrations
Monitored clinical safety of assigned products/projects, assessing adverse events and patient impact from technical complaints reported in studies, literature, and post-market surveillance.
Managed safety vendor(s) daily case processing operations, global ICSR submissions, and overall case quality in the global safety database.
Spearheaded the enhancement of safety strategy for BLA filings, involving phase 3 protocol review, ISS TLFs review, and SCS review.
Member of the Medical Review Committee (MRC) and the Promotional Material Review Team (PMRT)
Reviewed and approved medical and promotional pieces while collaborating with reviewers and stakeholder groups including MLR, compliance, and commercial teams.
Safeguarded scientific and medical accuracy of materials while providing adequate support and ensuring they remained current
Ensured accuracy and consistency of cited data with current medical literature and guidelines
Provided medical insights and utilized therapeutic medical expertise for MRC, PMRT
Ensured medical accuracy for diverse materials, such as disease awareness, marketing, and internal documents.
Supported cross-functional collaboration, aligning US and Global Medical Affairs projects.
Maintained high knowledge of emerging data and developments across therapeutic areas, proactively shaping medical and scientific discourse for products.
Authored SOPs, WIs, and corporate policies related to Safety and Pharmacovigilance Operations and Compliance tasks for global compliance with Health Authority regulations
Provided timely support in periodic review of aggregate safety data for potential trends and signals.
Performed signal detection activities and analysis supporting evaluation and characterization of safety topics.
Reviewed safety concerns from stakeholders and regulatory authorities. Collaborated with executive leadership to develop safety assessment strategies.
Authored, reviewed, and commented on Safety Data Exchange Agreements/Pharmacovigilance Agreements with business partners
Created, and maintained a safety quality management system and ensured a state of constant inspection readiness
Collaborated with key internal and external stakeholders to provide safety expertise and guidance for interdepartmental and cross-functional team deliverables
Worked cross-functionally to author, responses to health authority queries
Collaborated with Clinical Quality to establish Safety and Pharmacovigilance training programs for the Patient Safety and Pharmacovigilance department
Safety lead for audits and inspections
Responsible for identifying and following-up on corrective action plans and remediations
Compiled, analyzed, and interpreted clinical and scientific data from multiple sources, summarized safety trends with supervisory guidance
Prepared literature summaries on special topics to characterize product safety profile and support risk management documents
Established and maintained departmental procedures; oversaw training and continuous improvement
Supported DSP in pharmacovigilance activities including signal detection and tracking activities, literature surveillance, oversight of medical review performed by outsourced vendor
Collaborated with DSP safety physicians with PV activities
Wrote safety analysis reports
Drug development
Validated safety signals and led safety signal assessments
Developed and maintained Core Safety Information (core data sheet, core risks in informed consent forms, etc
Metadata repository
Prepared/reviewed core and regional risk management plans including additional risk minimization measures
Prepared/reviewed safety sections of periodic aggregate reports
Provided safety input to protocols, statistical analysis plans, and clinical study reports
Prepared/reviewed safety sections of new drug applications and regulatory filings
Digital data flow
Provided clinical functional review and expertise on the assigned projects/tasks
Responsible for timely authoring, revisions, updates on clinical related documents for Medical Device Regulation (MDR) remediation and Postproduction Risk Reviews (PPRRs)
Reviewed large documents such as literature reports, clinical research protocols, and reviewed template documents as assigned by the project lead
Assisted in literature review activities as assigned by the project lead and Franchise Head
Oversight of medical review and aggregate report activities performed by outsourced vendors
Supported clinical project teams for investigational products; provided project teams providing expertise in PV activities
Clinical data Standards
Collaborated with Clinical Research and Development, medical Affairs, Regulatory Affairs
Biometrics
Communicated and negotiated directly with co-developers/co-marketers/partners (e.g., distribution partners) and patient support program (PSP) / market research program (MRP) vendors (External Parties) related to development, implementation and maint
Supported development and implementation of systems and processes to monitor External Party compliance with PVAs
Documented registrations for the Americas region in the PVA global repository aPSP/MRP global repository, in collaboration with local PS
Implemented and maintained GPS Global Quality Procedures (GQPs) and Guidance Documents/Job Aids for External Party Agreements including PVAs, PSP/MRP agreements.
Provided support as subject matter expert regarding PVAs and PSPs/MRPs for internal audits and external inspections by regulatory authorities in the region.
Monitored and discussed safety signal evaluation topics.
Contributed to the writing and compilation of PADERs, Annual reports and PSURs/PBRER
Participated in Regulatory Inspections, external audits, and investigator meetings
Drug safety representative on intradepartmental committee for review and approval of clinical trial protocol language and clinical study processes
Managed and oversaw all product safety and pharmacovigilance activities throughout clinical development and post-marketing surveillance.
Responsible for the integration of pre-and post-marketing safety surveillance with Clinical Development and Medical Affairs activities and for ensuring an integrated and proactive approach to risk management
Provided medical and drug safety expertise for ongoing risk-benefit assessment and clinical trial data interpretation, collaborating with the Safety Scientist.
Ensured compliance with corporate SOPs, department SOPs, guidelines, and applicable regulations while overseeing DSPV processes.
Assessed safety data from different sources (pre-clinical and clinical trial data, post-marketing reports, scientific literature) to evaluate assigned products and development compounds.
Conducted safety signal detection activities, evaluated and interpreted the findings to ensure appropriate management and communication of safety information.
Led the Safety Review Team for assigned products and development compounds, overseeing ongoing cross-functional assessment of benefit risk profiles and related actions.
Contributed medical expert safety review input to essential documents used in clinical development of products, including protocols and amendments, ICFs, IBs, IMPDs, clinical research reports, INDs, and CTAs.
Collaborated with the Head of DSPV to formulate and execute safety and benefit-risk management plans for designated products
Created and developed Risk Management documents (RMPs, REMS) for assigned products
Assisted in creating periodic reports for assigned products, providing medical interpretation and reviewing/approving required reports.
Collaborated with global counterparts in Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, Marketing, Manufacturing, and Legal utilizing DSPV and medical knowledge.
Provided safety guidance to clinical development programs for assigned products and compounds.
Maintained accurate and up-to-date safety information in Company Core Data Sheet, Investigator Brochure, and labeling documents.
Ensured, in collaboration with Regulatory Affairs labeling team an accurate representation and communication of the safety profile of assigned products and development compounds
Managed and addressed safety inquiries from regulatory authorities
Provided integrated safety input into regulatory documents.
Provided Drug Safety input for product recall issues, Health Hazard Evaluations, and Dear Healthcare Professional letters.
Conducted medical review and oversight of adverse event reports, assessing seriousness, expectedness, and causality
Provided medical opinions to assist PV Scientists and safety vendors in obtaining follow-up information for individual cases.
Reviewed scientific literature to identify case reports meeting entry criteria for the safety database, as well as relevant safety articles and references related to active ingredients of marketed and developmental products. Created comprehensive literature summaries for inclusion in PSURs and other necessary reports.
Managed drug safety and pharmacovigilance operations executed with external partners and outsourced to vendors and contract research organizations.
Collaborated with clinical and regulatory counterparts to enhance safety and PV efforts. Provided valuable input for Investigator Brochures, development plans, clinical protocols, INDs/CTAs, regulatory responses, and risk management plans.
Supported and drafted responses to regulatory inquiries regarding DSPV issues for regulatory agencies, EC/IRB, investigators, and ad hoc inquiries.
Contributed to development of relevant DSPV safety reports including safety update and benefit risk evaluation reports.
Managed literature searches and review.
Collaborated with Safety Scientist to analyze and identify appropriate safety literature.
Assisted in developing and maintaining post-market surveillance plans, periodic safety updates, and product labeling.
Assisted in preparing health hazard assessments and responding to inquiries from health care authorities, professionals, and local affiliates.
Supported business development, license activities and health authority inspections/audits.
Managed adherence to regulatory compliance for drug product adverse events.
Successfully conducted MedDRA coding for Adverse Events.
Conducted thorough investigations into complaints, ensuring appropriate and effective resolution.
Collaborated with Product Safety Physician Leads (PSLs) and Safety Physicians to provide safety expertise for assigned developmental and marketed products.
Monitored the safety of patients on allocated clinical trials
Collaborated with Data Analytics, Biostats and Data Management to ensure outputs of safety data from both safety and clinical trial databases met preparation needs for aggregate safety reports such as DSUR, PBRER, and other required regulatory analyses.
Contributed to safety sections and reviewed aggregate reports such as PBRERs, DSURs, and PADER.
Assisted in enhancing integrated Benefit/Risk assessments.
Coordinated safety surveillance activities by reviewing scientific literature, SAE listings, and data outputs from safety and clinical databases in order to identify potential risks and emerging safety issues
Wrote and maintained RSI, CCSI, and contributed to safety summaries for CCDS and PI/SmPC Type II variations. Drafted justification documents and regulatory responses.
Collaborated with vendors, affiliates, and alliance partners to support patient safety operations in affiliates.
Identified, collected, analyzed, and visualized relevant data to support the GPS International Office and IOC.
Assisted the EU QPPV in maintaining the EU QPPV Office.
Managed and centralized patient safety operations information for affiliates
Monitored Key Performance Indicators (KPI's) linked to patient safety operations in affiliate health.
Regularly communicated updates on the International Office activities to the team.
Closely collaborated with vendors and business partners to enhance support for patient safety operations in affiliates
Supported review and analysis of relevant regulatory intelligence activities.
Analyzed the impact of PV regulatory changes on local, regional, and GPS wide PV systems
Facilitated relationships and communication between central GPS functions, cross-functional teams, and affiliate stakeholders to ensure efficient collaboration.
Collaborated with EU QPPV and regional/local QPPVs to enhance accuracy of PSMF documentation.
Coordinated and delivered safety-related documents such as PSMF.
Facilitated the QA Change Control process for GPS, ensuring patient safety in affiliates.
Championed patient safety values and principles while contributing positively to GPS' culture.
Facilitated distribution of critical safety information and actions to internal and external stakeholders, including DHCP/DHPC letters.
Managed and enhanced safety profiles for assigned products, including competitor offerings.
Wrote and reviewed safety sections, offering safety expertise in the creation of Protocols, IBs, ICFs, SAPs/ TFLs, Medical Monitoring Plans, and CSRs.
Managed and maintained ADR Summary and relevant project/study documents
Reviewed ICSRs from clinical trials and post-market settings for medical purposes.
Reviewed safety narratives for clinical study reports (CSR)
Supported signal detection in the development of new products.
Authored and maintained Risk Management Plans (RMP) for both EU and Core RMPs.
Provided expertise in medical safety, interpretation, review, and authorship for clinical documents like protocols and amendments, ICFs, IBs, and Signal Evaluation Reports by collaborating with cross-functional colleagues.
Represented Medical Safety Science in cross-functional team meetings and addressed questions/requests from clinical development, clinical operations, and medical writing teams.
Drafted Medical Safety Science SOPs, templates, and guidelines
Collaborated with Medical Safety Operations to develop processes and documentation for Safety Activities.
Provided technical file support for EUMDR remediation activities.
Created, edited, reviewed and approved comprehensive labeling documentation including device understanding, indications for use, alternative therapies, contraindications, clinical benefits, and required warnings.
Adjudicated adverse events for all products, ensuring accuracy, integrity, and completeness of safety information.
Participated in safety signal detection activities to enable identification, evaluation, and management of signals for marketed products including data analyses, interpretation of signals and trends, documentation, and risk communication with key stakeholders.
Provided evidenced-based and historical medical safety data to internal and external stakeholders, including Regulatory and Quality Assurance customers.

Summary

Overview

Work History

Pharmacovigilance / Medical Safety/Medical Reviewer

Regulatory Affairs Specialist

Education

Ph.D. - Clinical Medicine

Master of Science - Molecular Biology

Bachelor of Science - Molecular Biology

Skills

Timeline

Pharmacovigilance / Medical Safety/Medical Reviewer

Regulatory Affairs Specialist

Ph.D. - Clinical Medicine

Master of Science - Molecular Biology

Bachelor of Science - Molecular Biology

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