Pharmacovigilance and Regulatory Operations Expert

Michael Ushry

Clinical Research and Drug Safety Regulatory Operations Professional

Durham, NC

919-***-**** ************@*****.*** linkedin.com/in/michael-ushry

Professional Summary

Forward-thinking pharmacovigilance professional with extensive experience in drug safety operations and regulatory compliance. Demonstrated expertise in reviewing and evaluating adverse events and serious adverse event reports, ensuring timely and accurate submissions in accordance with global safety regulations. Contributes to risk management plans and signal detection activities while applying critical thinking to resolve complex safety issues. Recognized for strong cross-functional collaboration and commitment to continuous improvement in patient safety and regulatory adherence.

• Pharmacovigilance • Clinical Safety • Quality Assurance • Quality Control • Customer Service • Support Services • Project Coordination • Workflow Management • Project Planning • Risk Management • Regulatory Affairs and Strategy • Regulatory Reporting • Regulatory Submission • Regulatory Compliance • Audit & Inspection Readiness • Safety Reporting • ICSR Processing • Adverse Event (AE)/ Serious Adverse Event (SAE)/ Analysis of Similar Events (AOSE) Reporting • Electronic Trial Master File (eTMF)/ Record Keeping • Process Improvement • Content Management • Client Relationship Management • Project Management • Training & Development

Pharmacovigilance Skills

Risk Assessment & Mitigation

Program Evaluation

Documentation & Reporting

Cross-Functional Collaboration

Leadership & Staff Supervision

Regulatory Standards & Interpretation

Regulatory Documentation & Submissions

Regulatory Inspection Management

FDA Regulations

EMA Submissions

MHRA Submissions

IND / CTA Submissions

IRB Submissions

Safety Evaluations & Risk Assessments

Quality Systems

CAPA & Deviations

Clinical Trial Support

Clinical Trial Documentation

Clinical Trial Data Management

Study Management

Clinical Trial Coordination

ICH/GCP Guidelines

HIPAA

Healthcare Regulations

Data Collection

Data Entry (Physical & Digital)

Professional Experience

PAREXEL INTERNATIONAL, Durham, NC 06/2023 – 05/2025

Drug Safety Specialist

Conducted study-specific meetings to support clinical trial start-up (Phase I, II, III) and rescue drug safety trials.

Prepared and provided data in industry-standard formats for submission to regulatory authorities and ethics committees, ensuring compliance with expedited and periodic reporting requirements.

Managed the distribution of lifecycle safety data to investigators, marketing authorization holders, clients, and regulatory agencies within established deadlines.

Supported administrative and operational tasks including project start-up documentation, maintenance of project files, adverse event (AE) listings, and logistics coordination for clinical sites.

Coordinated internal team and client meetings, drafted meeting minutes, defined responsibilities, tracked progress, and ensured timely completion of clinical trial tasks.

Oversaw case intake and workflow assignment, ensuring adherence to company SOPs, work instructions, and global regulatory standards for drug safety operations.

Collected, tracked, and entered AE communications into lifecycle safety databases, monitored submissions, and maintained data integrity.

Supported internal and external audit preparation, corrective and preventive action (CAPA) documentation, and implementation activities.

Served as the primary client facing contact for departmental deliverables, ensuring transparency and timely communication.

Maintained a consistent record of 99% on-time safety submissions, meeting stringent regulatory reporting deadlines.

Ensured compliance with company operational standards and quality assurance requirements across all assigned projects.

Reviewing and analyzing clinical trial data for adverse effects or risks

Collecting, interpreting, and reviewing adverse event reports and other safety-related data

Preparing and submitting regulatory reports to health authorities

Ensuring compliance with safety surveillance regulations

Maintaining thorough and detailed records of all safety data

Collaborating with other departments such as clinical development, regulatory affairs, and medical affairs to ensure comprehensive safety evaluations

IQVIA (formerly Quintiles, Inc.), Durham, NC 04/2010 – 05/2023

Operations Specialist II (01/2021 – 05/2023)

Managed timely distribution of lifecycle safety data to investigators, marketing authorization holders, clients, and regulatory authorities in compliance with established deadlines.

Supported administrative and operational activities, including project start-up documentation, maintenance of project files, adverse event (AE) listings, and site logistics coordination.

Prepared and provided safety data in industry-standard formats for periodic regulatory and ethics committee reporting.

Assisted with project start-up tasks, ongoing maintenance of project documentation, periodic AE listing distribution, and shipment of study materials to clinical sites.

Coordinated team, department, and customer meetings, including calendar management, agenda preparation, action-item tracking, and alignment on project objectives.

Promoted compliance with work instructions for electronic systems and ensured accurate maintenance of safety and project records.

Oversaw case intake and archiving processes, ensuring consistency and data integrity across multiple coordinators.

Executed responsibilities in accordance with drug safety clinical trial and post-marketing SOPs, work instructions, and global regulatory requirements.

Processed incoming and outgoing lifecycle safety data and reports, including collection, tracking, and status management of AE and endpoint reports.

Entered and maintained safety data in lifecycle safety databases, submitted event data to operational teams, and tracked workflows for assigned projects.

Prepared documentation for meetings and committees, including endpoint duplication reviews, dossier compilation oversight committees, and other project-related forums.

Created, tracked, archived, and retrieved case folders and project files across lifecycle safety service lines; supported document control room operations and safety systems as directed.

Performed work in accordance with contracted budgets and work orders. Proactively brought change order and out of scope task to the attention of the Project Manager and/ or Client.

Operations Specialist I (12/2016 – 01/2021)

Organized and maintained all files related to regulatory actions.

Monitored regulatory changes required by new and revised laws and regulations, communicating complex protocols and determining operational impacts.

Oversaw case intake and archiving processes, ensuring consistency and data integrity across multiple coordinators.

Responsible for regulatory reportability assessment.

Entered and maintained safety data in lifecycle safety databases, submitted event data to operational teams, and tracked workflows for assigned projects.

Provided data in the industry standard format for onward reporting to the regulators and ethics committee to fulfill expedited and periodic regulatory reporting requirements (e.g., CIOMS 1, MedWatch, and CIOMS Line Listing).

Submitted alert letters (AL) to the investigators.

Created, tracked, archived, and retrieved case folders and project files across lifecycle safety service lines; supported document control room operations and safety systems as directed.

Operations Coordinator (04/2010 – 12/2016)

Managed daily deskside and operational support functions, defining and implementing efficient processes to support lifecycle safety and clinical trial activities.

Processed incoming and outgoing lifecycle safety data, including adverse event (AE) and endpoint reports; determined initial and follow-up statuses, tracked timelines, and ensured on-time completion.

Entered and maintained safety data in lifecycle safety databases; coordinated submissions, tracked workflows, and supported assigned projects in collaboration with operations teams.

Prepared, organized, and maintained documentation for meetings and oversight committees, including endpoint duplication and dossier compilation committees.

Coordinated and quality-checked incoming site documentation using standardized checklists to ensure compliance prior to secondary review.

Created, tracked, archived, retrieved, and maintained case folders and project files across lifecycle safety service lines; supported document control room activities and relevant systems.

Assisted with the distribution of lifecycle safety data to investigators, marketing authorization holders, sponsors, and regulatory authorities.

Coordinated, scheduled, and submitted regulatory reports in accordance with established deadlines and regulatory requirements.

Supported investigator communications and mailings, including label creation, document preparation, courier dispatch, tracking, and filing of submitted materials.

Supported project start-up and administrative activities, including AE listings distribution, project file maintenance, and shipment of study materials to sites.

Oversaw case intake and archiving processes, ensuring consistency and accuracy when coordinating with multiple team members.

Identified, escalated, and resolved issues related to document tracking, data intake, and process systems, including incoming communication discrepancies.

Coordinated and supported daily clinical trial operations, tracking study progress, managing timelines, and addressing operational challenges.

Assisted in the development and maintenance of standard operating procedures (SOPs), work instructions, and compliance documentation.

Supported audit and inspection readiness activities by ensuring documentation accuracy, completeness, and regulatory compliance.

Collaborated cross-functionally with operations, quality, and other stakeholders to achieve project and business objectives.

Actively participated in departmental committees and initiatives focused on engagement, quality improvement, and administrative excellence.

Performed all duties in accordance with SOPs, GCP, ICH guidelines, and applicable regulatory requirements.

Previous Experience

PROFESSIONAL RECOVERY CONSULTANTS, INC., Durham, NC

Compliance Officer (Third Party Debt Collection) (07/2003 – 01/2010)

Interpret and Implement Regulatory Requirements

oStudied applicable laws, regulations, and industry standards, then convert them into clear, actionable internal policies.

Conducting Ongoing Risk Assessments

oIdentify, evaluate, and monitor risks that might expose the organization to legal or ethical issues. By analyzing business processes, systems, and behaviors. These assessments guide proactive decision-making, support mitigation plans, and help leadership allocate resources wisely to reduce exposure.

Design and Maintains Internal Policies (Professional Practices Management System – PPMS)

oCreate agreed upon policies, procedures, and codes of conduct that reflect regulatory demands and internal values.

Lead Compliance Training and Awareness Programs

Educate employees through training sessions, workshops, and ongoing reminders about key compliance topics. By raising awareness and reinforcing ethical behavior, they build a culture of responsibility and transparency.

Oversaw, Monitoring, and legal discussions.

Conduct Internal audits, track adherence to policies, and monitor for deviations.

oMaintain documentation that supports regulatory audits and communicates findings to leadership.

Act as an Ethical and Strategic Advisor

Beyond enforcing rules, I helped to shape the organization’s ethical standards and long-term compliance strategy. Collaborate with leadership to balance business goals with regulatory expectations.

Data Entry Clerk (04/1998 – 06/2003)

Entering Data: Typing information from physical documents or digital sources into computer systems or databases.

Verifying Accuracy: Reviewing data for errors or missing details and correcting any mistakes to ensure all records are correct and complete.

Maintaining Records: Keeping files organized, updating existing data, and managing both digital and paper filing systems.

Handling Confidential Information: Managing sensitive information, such as customer records or financial data, while following privacy and security guidelines.

Using Office Software: Working with tools like spreadsheets, word processors, and database programs to enter and organize data efficiently.

Education

Major: Art and Mass Communication, University of North Carolina at Asheville, Asheville, NC

COMPUTER SKILL/ TECHNOLOGY

Microsoft Systems

Safety Systems

Quality Management Systems

Other

Microsoft Word

Argus

Trackwise

CTMS

Microsoft Excel

Aris G

Wingspan

Microsoft Project

Veeva Vault

PowerPoint

Citrix

OneNote

Phlex

Sharepoint

Radar

Apex

SOFT SKILLS

• Relationship Building • Analytical & Quantitative Skills • Communication Skills (Written and Verbal) Interpersonal Skills • Ability to Collaborate • Problem Solving & Root Cause Analysis • Ability to Lead • Active Listener • Teamwork • Time Management • Leadership • Strategic Thinker • Business Acumen • Attention to Detail • Problem Solver • Analytical Skills • Open Minded • Eager to Learn • Present Information

Contact this candidate