PRIYA TYAGI
Montreal,QC
Summary
Dynamic, Dedicated, Attentive and goal-focused professional who brings successful approach to cultivating complex best practices to meet organizational and regulatory expectations. Detail-oriented focus on achieving expected outcomes. Enthusiastic hard worker with expertise in cultivating lucrative client relationships and Healthcare Compliance. Extremely familiar with laboratory procedures, clinical trials and Clinical Study Reports (CSRs). Dependable and organized team player with the ability to communicate effectively and efficiently. Possess a strong work ethic and a passion for biotechnology.
Overview
8
8
years of professional experience
Work History
Healthcare Compliance Associate Consultant
Custom Healthcare Compliance Solutions
Montreal, QC
03.2023 - Current
- To manage risks related to international healthcare fraud and abuse laws.
- Experience with MediSpend and Oracle system.
- To review Japan and EMEA engagements and sponsorship requests from compliance perspective.
- Experience with Fair Market Value (FMV) calculations.
- To prepare SOPs, one pagers and training presentations according to client policies.
- Detail knowledge of Annual Needs Assessment.
- Being involved in various research projects related to healthcare laws in US, Asia and EMEA.
- Maintained compliance frameworks, policies and documentation to support audits.
- Organized training programs to educate company staff on benefits and consequences of complying or defying regulations.
- Developed and implemented strategies necessary for minimizing risk of non-compliance.
- Stayed abreast of applicable laws and state or federal regulation to report violations.
- Monitored compliance risk controls to identify deviations and offer recommendations.
- Conducted reviews to foster ongoing compliance with federal and local regulations.
- Established internal controls and processes to support compliance through project management and engagement of key stakeholders.
- Participated in networking and learning opportunities to remain current with evidenced-based practices.
Scientific Report Associate, Clinical Pharmacology
Celerion Inc
Montreal , QC
06.2022 - 03.2023
- Setting up and templating Clinical Study Reports (CSRs), pulling information contained in the protocol, SAP(statistical analysis plan),Clinical summary, clinical safety and PK/PD tables and figures.
- Building the CSR appendices by pulling clinical safety and PK/PD TFL (Tables, Figures and listings) and all necessary documents
- Formatting the CSR as per the sponsor's specifications.
- Assisting in writing the CSR sections as requested by the Report Lead.
- Review CSR and formatting.
- Assisting in maintenance of institutional knowledge or ISMs (client specifications).
- Managing different clinical studies with accuracy and attention to details.
- Compliance with ICH guidelines.
- Experience with Veeva Vault.
- Proficienct in MS office products (MS word, powerpoint, excel)
- Proficienct in Adobe Acrobat and use of plug ins in pdf.
Associate Scientist - (Virology Platform)
Nexelis
Montreal, QC
06.2021 - 05.2022
- Planning and executing laboratory experiments following the Standard operating procedures (SOP)
- Analyze the results obtained and synthesize them as needed.
- Good Documentation Practices (GDP)
- Good Clinical Laboratory Practices (GCLP)
- Good Laboratory Practices (GLP)
- Good Manufacturing Practices (GMP)
- Performing Pseudotype Virus Neutralization Assay (PNA) for SARS CoV2.
- Performing ELISA (Enzyme-Linked Immunosorbent Assay)
- Maintenance and calibration of instruments when necessary.
- Involved in the Pre-clinical and Clinical trials including Phase I, Phase II and Phase III.
- Coded proficient SoftMax templates to automate data interpretations and results.
- Meticulously reported on phases during experiments and kept records of unexpected outcomes.
- Developed reports and recommendations regarding research outcomes.
- Maintained field equipment and performed troubleshooting techniques to keep tools fully operational.
- Efficient in working with Pipetting Robots and Vialab Programs associated with it.
- Small molecule drugs experience.
- Knowledge of Antibodies and Pharmacokinetics.
- Fast faced environment experience.
Data Organizer (Part Time)
Kreye Agency
Montréal, Quebec
11.2021 - 01.2022
- Digitization of the Medical Files
- Good Documentation Practices
- Good Organization Skills
- Attention to detail
- Handled the medical records and organized them efficiently.
Microbiology Technician (Diagnostics Department)
Merieux Nutrisciences
Dorval, Canada, Canada
12.2019 - 05.2021
- Performing various microbiological tests according to the SOPs approved by Health Canada.
- Quantitative and Qualitative analysis of various food and environmental samples.
- Running PCR for Listeria, Salmonella and E.coli.
- Performing confirmation tests for Listeria, Salmonella and E.coli.
- Detailed knowledge of how to run a BAX machine and Vidas Machine.
- Basic Understanding of different types of media used for different analysis.
- Maintaining Good Lab Practices.
- Actively participating in microbiological investigations and discussions.
- Sufficient knowledge of LIMS (Laboratory Information Management System)
- Monitored lab supplies and proactively replenished for convenience and availability.
- Adhered to all laboratory requirements and enforced compliance with regulations.
Research Assistant
Dayanandan Laboratory, Concordia University
Montreal, Canada, Canada
09.2018 - 08.2019
- Title - Interaction of Populus endophytic fungal microbiome with its pathogen Septoria musiva Aim – To gain insights into the processes underlying the origin and maintenance of biological diversity with specific focus on ecology, evolution and genomics of forest trees and understanding the causes and consequences of forest fragmentation.
- Responsibilities: Performing basic microbiological experiments.
- Fungal DNA isolation, PCR, sub culturing of different fungi, and fungi revival techniques.
- Researching and reviewing literature.
- Commended by the supervisor and other professors for accuracy and excellent presentation skills.
Intern
Rajiv Gandhi Cancer Institute and Research Centre
New Delhi, India, India
06.2016 - 08.2016
- Contributed research and presentation expertise in the review of Childhood Acute Lymphoblastic Leukemia: Drug metabolism and toxicity of drugs used in chemotherapy.
- Responsibilities: Assisted in research and writing review articles on Childhood Leukemia.
- Worked closely with and for the children suffering from Leukemia.
- Reviewed metabolic pathways and the genes involved in the metabolism of different chemotherapy drugs such as Vincristine, Dexamethasone and Methotrexate.
- Studied and learned the husbandry of Drosophila melanogaster: as a model system for the drug toxicity.
- Commended by the head supervisor for research and communication skills.
Education
Certificate - European Healthcare Compliance Program
Seton Hall University School of Law
Newark, NJ, United States06-2024
Graduate Diploma - Biotechnology and Genomics
Concordia University
2019
Bachelor of Science - Biotechnology
Panjab University
2017
Certificate - Clinical Research Associate Training
Clinical Research Networking, LLC
Florida, United StatesSkills
- Basic knowledge of Oxford Nanopore Technology and Illumina Technology
- Basics of R Programming language, Machine Learning and Microsoft office
- Excellent communication Skills
- Creative Presentation Skills
- Exceptional attention to detail
- Ability to work under pressure
- Ability to maintain quality, safety and infection control standards
- Exceptional interpersonal and organization skills
- Excellent work ethic
- Good Clinical Laboratory Practices (GCLP)
- Ability to work efficiently in a fast paced environment
- Knowledge of immunological assays like ELISA, ELLA, and PNA
- Knowledge of Antibodies and Pharmacokinetics
- Experience with Small molecule drugs
- Knowledge of Clinical trials
- Event coordination
- Development and qualification reporting
- Research management
- Lab experiments and research
- Process automation and optimization
- Data accuracy
- Safety processes and procedures
- Public speaking
- Data analytics
- Clinical Research Monitoring
Accomplishments
- Actively attended a workshop on “Intellectual Property Rights and regulatory perspectives for Pharma and Biotech Sectors.”
- Actively participated in Toastmasters Club meetings at Concordia University, Canada.
- Awarded a certificate of appreciation for successfully completing the Public Speaking, Communication and Leading Course (March – April 2019) at Grad Pro skills, Concordia University.
- Bagged first prize in intercollege declamation competition.
- VOLUNTEERING/COMMUNITY SERVICE - Actively volunteered for United Nation's “COP-15" Biodiversity conference in Montreal.
Languages
- English| Spoken and Written
- Hindi| Spoken and Written
- French | Spoken and Written (Elementary)
Additional Information
- Canadian Citizen
- Eligible for Youth Mobility Scheme Visa
References
References available upon request.
Timeline
Healthcare Compliance Associate Consultant
Custom Healthcare Compliance Solutions
03.2023 - Current
Scientific Report Associate, Clinical Pharmacology
Celerion Inc
06.2022 - 03.2023
Data Organizer (Part Time)
Kreye Agency
11.2021 - 01.2022
Associate Scientist - (Virology Platform)
Nexelis
06.2021 - 05.2022
Microbiology Technician (Diagnostics Department)
Merieux Nutrisciences
12.2019 - 05.2021
Research Assistant
Dayanandan Laboratory, Concordia University
09.2018 - 08.2019
Intern
Rajiv Gandhi Cancer Institute and Research Centre
06.2016 - 08.2016
Graduate Diploma - Biotechnology and Genomics
Concordia University
Certificate - Clinical Research Associate Training
Clinical Research Networking, LLC
Certificate - European Healthcare Compliance Program
Seton Hall University School of Law
Bachelor of Science - Biotechnology
Panjab University
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