Sarah Nazar
San Diego,CA
Summary
Results-oriented consultant with a background in formulating and executing successful business strategies. Demonstrated ability in recognizing opportunities for operational enhancement, driving productivity, and leading change management efforts. Proficient in project management, strategic planning, and team leadership. Significantly contributed to advancing organizational expansion and financial performance in prior positions.
Overview
13
13
years of professional experience
Work History
Pharmacovigilance Consultant
Xencor
San Diego, CA
12.2022 - Current
- Develop and implement Safety Management Plans, ensuring regulatory compliance and mitigating clinical trial risks
- Lead safety database initiatives, managing SAE records and reconciliation to improve data accuracy and trial integrity
- Collaborate with cross-functional teams to ensure efficient project execution and document control
- Conduct literature reviews and manage SUSAR reconciliation to enhance pharmacovigilance processes
- Support drug safety initiatives, overseeing procedures to ensure compliance with U.S
- And global regulations
- Supervise safety service vendors in PV activities such as case processing, SAE reconciliation, and document updates
- Review and develop SOPs, aligning them with regulatory standards and company policies
- Participate in signaling activities, annual report writing, and cross-departmental collaborations
- Oversee clinical research organizations (CROs), ensuring data integrity, compliance, and effective case processing/reporting
- Coordinate efforts between sponsors, Safety and Clinical CROs, and update study-related documentation
- Assist in transitioning Safety activities between CROs, supporting data migration, quality control, and reconciliation processes
- Conduct QC of cases, maintain safety documentation, and support regulatory submissions and study initiation activities
- Mentor and train staff, developing training materials and overseeing SOP and guideline updates for PV processes
- Participate in audits, monitor vendor compliance, and develop QA templates to assess performance
- Contribute to clinical protocol development, safety management plan creation, and case report reviews for regulatory submissions and signal detection
- Coordinate with departments and external partners to standardize PV procedures and ensure regulatory adherence.
Senior Manager, Onboarding and Customer Support
MMG Fusion
San Diego, CA
07.2016 - 11.2022
- Led a team of 8 in the successful delivery of multi-functional projects for B2B SaaS platforms
- Directed global IT teams to ensure proper UAT testing protocols and system design integration, improving system efficiency by 15%
- Implemented Agile methodologies, managing sprint planning, daily scrums, retrospectives, and product reviews
- Developed product roadmaps, aligning with stakeholder objectives and business needs
- Created and tested user stories for enterprise-level commercial software products, enhancing product functionality by 20%
- Monitored key performance indicators (KPIs) and reported project status to senior leadership, improving transparency and decision-making
- Led risk management efforts by identifying project risks and implementing mitigation strategies, reducing project delays by 10%
- Managed a $500K annual budget and spearheaded post-launch support strategies for customer success, improving client satisfaction rates by 25%
- Collaborated with stakeholders to define project scope, ensuring alignment with customer needs and company goals
- Spearheaded continuous improvement initiatives, streamlining onboarding processes and reducing time-to-value for new clients by 30%.
Senior Project Manager
Local Patient
Washington, D.C.
01.2012 - 06.2016
- Led cross-functional teams in delivering complex B2B SaaS platform enhancements and system integrations
- Coordinated UAT testing with global IT and development teams to ensure seamless system implementation
- Directed Agile sprint activities, creating and managing user stories for software product development, resulting in a 20% increase in development velocity
- Managed a team of 8 and an annual budget of $500K, ensuring successful project outcomes and on-time delivery
- Conducted stakeholder analysis and facilitated workshops to gather requirements and prioritize feature development, improving project delivery by 15%
- Utilized project management software to streamline task tracking, resource allocation, and timeline management, improving project execution efficiency by 10%
- Led vendor contract negotiations, ensuring timely delivery of cost-effective solutions and reducing operational costs by 8%
- Established project governance frameworks, overseeing project documentation and decision-making processes to ensure alignment with organizational goals
- Developed comprehensive training programs for internal teams, facilitating knowledge transfer and process improvement, reducing onboarding time by 20%.
Education
Bachelor of Science in Business Administration -
Liberty University
Lynchburg, VAAssociate of Arts and Sciences in International Marketing -
Northern Virginia Community College
Annandale, VASkills
- Pharmacovigilance
- Oracle Argus
- Agile (Scrum, Kanban)
- Jira
- System Design
- UAT
- SaaS Platforms
- Technical Skills
- Microsoft Office (Excel, PowerPoint, Word)
- Salesforce CRM
- UI/UX Prototyping
- Enterprise Reporting
- Microsoft Azure AI
- Data Management
- SQL
- Veeva
- SharePoint
- Languages (English/Russian/Farsi)
Volunteer Experience
- Humane Society of Virginia & Washington, D.C., 2009, 2015
- Feeding San Diego / Food Distribution Center, 2022, Present
Timeline
Pharmacovigilance Consultant
Xencor
12.2022 - Current
Senior Manager, Onboarding and Customer Support
MMG Fusion
07.2016 - 11.2022
Senior Project Manager
Local Patient
01.2012 - 06.2016
Bachelor of Science in Business Administration -
Liberty University
Associate of Arts and Sciences in International Marketing -
Northern Virginia Community College
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