Chun M. Ng, PharmD.
Brooklyn,NY
Summary
Dedicated and proactive Pharmacovigilance (PV) Associate with five plus (5+) years of valuable experience learning and refining expertise in drug safety surveillance and adverse event management. Eager to take the next step in professional growth and contribute to ensuring drug safety and minimizing potential risks. Committed to upholding the highest standards of patient safety and product quality within the pharmaceutical industry.
Overview
5
5
years of professional experience
Work History
Global PV Harmonization and Optimization Associate
Advanced Clinical
Princeton, NJ
11.2022 - Current
- Identify business requirements and negotiate Pharmacovigilance Agreements and Safety Management Plans with partnered Clinical Research Organizations and vendors. Ensure compliance oversight to meet regulatory standards and operational objectives.
- Manage a team of three professionals, providing leadership, guidance, and support to achieve departmental goals in pharmacovigilance operations and compliance.
- Lead a project to overhaul the department's training program, resulting in a significant reduction of the onboarding process duration by half. Improve training effectiveness and streamline onboarding procedures for new team members in pharmacovigilance operations.
- Utilize best practices and relationship-building to break down silos between Global Pharmacovigilance (GPV) Case Management and cross-functional teams. Enhance collaboration efficiency, enabling timely delivery on compliance objectives and fostering a cohesive operational environment.
- Effectively manage two safety inboxes, overseeing the intake, processing, and management of safety-related inquiries.
- Play a key role in a medical literature review committee focused on pharmacovigilance (GPV) related decisions. Evaluate and synthesize medical literature to inform critical safety assessments and regulatory compliance strategies, ensuring robust decision-making and alignment with global pharmacovigilance standards.
COVID-19 Otsuka Medical Safety Advisory Member
Advanced Clinical
Princeton, NJ
04.2020 - 03.2022
- Provided real-time data to a multidisciplinary team of medical experts to drive safe logistics advisory during the pandemic, ensuring timely and informed decision-making.
- Created a Frequently Asked Questions (FAQ) document utilizing diverse public domain references (e.g., CDC, EMA) and clinical literature. Included comprehensive information on COVID-19, covering virulence, infection rates, symptoms, transmission control measures, and all types of interventions from emergency use authorizations to available vaccines.
- Aided in developing policies and procedures for members to safely return to the office during the COVID-19 pandemic, incorporating public health guidelines and ensuring a safe working environment for all staff.
Global PV Operations Associate
Advanced Clinical
Princeton, New Jersey
11.2019 - 10.2022
- Upheld optimal drug safety compliance through oversight, performance evaluation, and quality assurance of case processing. Engaged in clinical initiatives to enhance pharmacovigilance practices and ensure regulatory adherence.
- Proficiently collected, processed, analyzed, and evaluated adverse events reported by healthcare professionals. Collaborated with Medical Safety Physicians to assess complex cases, ensuring regulatory compliance and timely resolution.
- Supported and improved Individual Case Safety Report (ICSR) activities and procedures to streamline processes and enhance reporting accuracy, contributing to efficient pharmacovigilance operations.
Education
Doctor of Pharmacy -
Touro College of Pharmacy
New York, NY06-2019
Bachelor of Science - Biomedical Sciences
Inter American University of Puerto Rico Metropolitan Campus
San Juan, PR05-2013
Skills
- Teamwork and Collaboration
- Product Knowledge
- Medical Writing
- MedDRA Coding
- Scientific Communication
- Safety Compliance
- Performance Improvement
- Data Entry
- Pharmaceutical knowledge
- Case Processing
- Drug Safety Monitoring
- Pharmacovigilance Regulations
Affiliations
- Salsa, Bachata, and Brazilian Zouk partner dancing
- Basketball
- Dog Training
- Soccer Dad
- Food Enthusiast
Languages
Spanish
Native/ Bilingual
Accomplishments
- Gold Star Award, Dec. 2020
- Phi Lambda Sigma Pharmacy Leadership Society, Nov. 2017 - Present
References
References available upon request.
Timeline
Global PV Harmonization and Optimization Associate
Advanced Clinical
11.2022 - Current
COVID-19 Otsuka Medical Safety Advisory Member
Advanced Clinical
04.2020 - 03.2022
Global PV Operations Associate
Advanced Clinical
11.2019 - 10.2022
Doctor of Pharmacy -
Touro College of Pharmacy
Bachelor of Science - Biomedical Sciences
Inter American University of Puerto Rico Metropolitan Campus
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