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Skills

Adverse drug reaction (ADR) mitigation strategies
Interdisciplinary teamwork with regulatory and clinical teams
Organization
Health Authorities safety reporting
Case triage process implementation
Materials inspections
Compliance with Good Pharmacovigilance Practices (GVP)
Pharmacovigilance process automation
Problem resolution
Internal stakeholder communication for safety data

Work Experiences

Achieved approvals across 3 markets.
Performed cell-based potency and impurity assays for in-process, release, and stability samples.
Assessed adverse events.
Oversaw testing procedures and ensured that tests were carried out in accordance with item specifications and protocol.
Technical documents such as deviation reports, testing protocols, and trend analyses were all written by me.
Authored and reviewed Risk Management Plans (RMP) for Salesforce to mitigate safety risks, significantly reducing the occurrence of adverse drug reactions (ADRs) by 43%.
Inspected Jira and compared it to industry standards to meet regulatory requirements.
Avoided regulatory penalties.
Addressed compliance gaps.
Contributed to a post-market surveillance program.

Summaries

Adept in aligning cross-functional teams.
Dedicated to learning, growing, and succeeding in Miscellaneous.
Avoided regulatory actions.
Strengths in vendor management and team leadership backed up by Miscellaneous training.
Conducted safety database reconciliation.
Quality Control Analyst with experience testing Workday and Miscellaneous products.
Recognized for motivating management team members to achieve their goals and fostering innovative work environments.
Bolstered team productivity.
Strong experience collecting and analyzing quality metrics as well as making recommendations for process and quality improvement.
To conduct experiments successfully, pays close attention to detail and uses critical reasoning.

Accomplishments

Streamlined pharmacovigilance database management, reducing discrepancies in adverse events (AEs) reporting data by 21% across 12 regions.
Collaborated with cross-functional teams in the development of safety signal management strategies, addressing 9 key safety concerns.
Implemented Machine Learning tools into pharmacovigilance processes, reducing manual data review by 63% and saving 8 annually.
Resolved product issue through consumer testing.
Conducted regular benefit-risk assessments that impacted safety decisions for category, enabling timely safety alerts and updates to stakeholders.
Advanced the implementation of expedited AE reporting processes, ensuring a 50% reduction in reporting delay to regulatory bodies.
Managed the implementation of root cause analysis techniques for AE reporting issues, reducing reporting inconsistencies by 37%.
Developed and presented quarterly benefit-risk assessment reports for metric, aligning safety concerns with ongoing post-market surveillance findings.
Monitored adverse event data for 18 clinical trials, identifying key trends and forwarding critical safety issues to regulatory authorities.
Spearheaded the automation of signal detection workflows using SAP, improving early detection of safety issues by 32%.

Affiliations

Project Management Institute
European Society of Clinical Pharmacy (ESCP)
Member of the International Conference on Pharmacoepidemiology & Therapeutic Risk Management
Toastmasters
Society for Clinical Data Management (SCDM)
International Society of Pharmacovigilance (ISoP)
American College of Clinical Pharmacy (ACCP)
Association for Computing Machinery
European Medicines Agency Pharmacovigilance Risk Assessment Committee (PRAC)
Medical Affairs Professional Society (MAPS)

Certifications

Pharmaceutical Safety and Risk Management Certificate from Cedar Works
Certified Public Accountant (CPA)
ServSafe
ICH E2E Pharmacovigilance Certification from procedure
Certified Business Analysis Professional (CBAP)
Google Certified Professional Cloud Architect
MedDRA Coding Certification from standard
ICH Good Clinical Practice (GCP) E6(R2) Certification
Certified Expert in Periodic Safety Update Report (PSUR) Writing
Compliance with Medicines and Healthcare Products Regulatory Agency (MHRA) Standards

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