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Skills

  • First Aid/CPR
  • Clinical Quality Improvement
  • Advanced ADR (Adverse Drug Reactions) Monitoring
  • Tracking client progress
  • Confidential records
  • Implementation of Safety Tracking Software
  • Organization
  • Disease Diagnosis and Management
  • Efficient Case Processing
  • Planning and coordination

Work Experiences

  • Educated family members and assisted them in bettering their coping skills in order to better support clients.
  • Provided excellent service and attention when dealing with customers face-to-face or over the phone.
  • Answered 4 phone calls per several months to assist customers.
  • Contributed to authoring key Risk Management Plans (RMPs).
  • Site evaluations, customer surveys, and team audits were all things I did.
  • Collaborated with cross-functional teams to streamline pharmacovigilance processes for Tableau, resulting in a 23% reduction in adverse event processing time.
  • Achieved zero critical findings.
  • Achieved a 43% decrease in processing errors.
  • Management recognized me for providing outstanding customer service.
  • Assisted in the creation of category procedures.

Summaries

  • Strategic thinker with expertise in project management.
  • To mitigate the effects of standard problems in vulnerable populations, spearhead successful therapeutic initiatives, prevention strategies, and educational approaches.
  • Scrum Master certified
  • Senior Drug Safety Associate and team leader with 7 years of experience in process settings.
  • Motivating leader who has built and managed program teams in the past.
  • Achieved zero major findings.
  • Results-oriented Miscellaneous professional with performance reporting, project management, and data analysis strengths.
  • Analytically minded safety professional with extensive experience in monitoring ongoing safety signals using real-time surveillance tools.
  • Communicative and team-oriented, with Salesforce expertise.
  • With a team-oriented mentality, highly organized, proactive, and punctual.

Accomplishments

  • Optimized safety submission workflows using HubSpot software, driving a 39% reduction in manual workload while enhancing overall case processing efficiency.
  • Managed the regulatory reporting of serious adverse events (SAE) within required timelines across multiple markets, achieving 20% on-time submissions.
  • Trained and mentored cross-functional teams on pharmacovigilance regulatory requirements, boosting team comprehension and overall efficiency by 48%.
  • Investigated pharmacovigilance case discrepancies and partnered with teams to remediate non-compliance, achieving a 82% increase in data accuracy.
  • Pioneered cross-functional audits focused on compliance with international pharmacovigilance requirements, reducing overall non-conformance incidents by 81% in 17 months.
  • Enabled rapid resolution of safety-related queries by updating standard reporting processes based on real-time feedback from regulatory bodies and stakeholders.
  • Monitored post-marketing adverse event data and led signal detection activities for system, informing risk assessments that reduced safety concerns by 15%.
  • Orchestrated global literature surveillance across the Southwest, capturing and documenting emerging safety concerns for SAP, shared with 5 internal stakeholders on a weekly basis.
  • Fostered collaboration between safety, clinical, and regulatory teams, improving the accuracy of safety reporting data and reducing interdepartmental discrepancies by 17%.
  • Enhanced collaboration with third-party vendors by strengthening contractual agreements and introducing quarterly performance reviews, resulting in a 35% drop in overdue cases.

Affiliations

  • Member of the American Pharmacists Association (APhA) for professional development in safety operations and adverse event reporting.
  • Certified Pharmacovigilance Professional through the Institute of Pharmacovigilance, earned in 2017, focusing on post-market signal detection methods.
  • Attended Postgraduate Program in Drug Regulatory Affairs with a pharmacovigilance specialization through program in 2016.
  • Participation in the National Council for Prescription Drug Programs (NCPDP) taskforces for refining adverse event reporting technologies.
  • Active member of the Health Level 7 (HL7) International, contributing to the standardization of health data exchange relevant to pharmacovigilance.
  • Contributing member of AdvaMed’s pharmacovigilance working group, assisting in the development of device-related safety data exchange agreements.
  • Accredited by the International Society of Pharmacoeconomics and Outcomes Research (ISPOR) in leveraging health economics in safety assessments of drugs.
  • Active involvement in the European Medicines Agency (EMA) special interest groups on Risk Management Plan (RMP) development for Power BI.
  • Member of Drug Information Association (DIA) since 2020, actively participating in educational workshops on pharmacovigilance practices.
  • Affiliated with the Pharmaceutical Users Software Exchange (PhUSE) for seminars on data standards in pharmacovigilance and signal management.

Certifications

  • Regulatory Affairs Certification (RAC) - Drugs
  • Certified Adverse Event Coordination Specialist (CAES)
  • Pharmaceutical and Regulatory Affairs Certification
  • CompTIA Security+
  • Project Management Professional (PMP)
  • Clinical Trial Regulatory Compliance Certification
  • SHRM Senior Certified Professional (SHRM-SCP)
  • Association for Project Management (APM)
  • Microsoft Office Specialist (MOS)
  • Salesforce

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