Nasim Sarjany
Ottawa,Canada
Summary
I am a bilingual, detail-oriented, hardworking, motivated, and enthusiastic scientist committed to helping protect the interests and well-being of Canadians and the environment. I have a security clearance and experience in research, industry, and regulatory affairs, including the Marketed Health Products Directorate and the Medical Devices Directorate. I always strive to achieve the highest level possible for any given task. I am accustomed to working in a challenging environment, including managing multiple projects.
Overview
7
7
years of professional experience
Work History
Scientific Evaluator (BI-03)
Health Products and Food Branch, Marketed Health Products Directorate, Marketed Pharmaceuticals Bureau, Scientific Section of Opioids
Ottawa, Ontario
07.2022 - Current
- Assess scientific data and information related to the safety and effectiveness of marketed drugs intended for human use to ensure the manufacturer’s compliance with the requirements of the Food and Drugs Act and Regulations in the context of existing standards, policies, procedures, and guidelines
- Review periodic safety update reports (annual summary reports), adverse reaction case reports, risk management plans, product monograph, and safety information to identify signals and health hazard issues of post-approval marketed drugs and provide recommendations to supervisors for revisions to product monographs to reflect scientifically valid issues arising from post-approval benefit/risk assessment
- Assess compliance of industry with the Adverse Reaction Reporting Guidelines, ICH, and other Guidelines by requesting additional pharmacovigilance, drug safety data, and information from the manufacturer to address deficiencies in the Periodic Safety Update Reports and Summary Reports
- Provide critical scientific and regulatory advice on safety and effectiveness information to management as part of benefit/risk re-assessments of post-approval therapeutic products and make regulatory recommendations under the Food and Drugs Act and Regulations
- Conduct supplementary research, literature searches, and work with other branches to obtain additional scientific and medical information to identify and extract information to complete scientific reviews
- Attend and participate in national and international conferences (PRAC and IPMS) to discuss and exchange scientific information related to a drug
- Discuss priorities and workload, providing a monthly update of the section's workload to the manager
- Participate as a team member on internal working groups, committees, professional meetings, and working groups
- Present new potential safety concerns at MPB signal validation and prioritization meetings.
Acting Scientific Evaluator (BI-04)
Health Products and Food Branch, Marketed Health Products Directorate, Marketed Pharmaceuticals Bureau, Scientific Section of Opioids
Ottawa, Ontario
11.2023 - 03.2024
- Managed complex files and provided scientific evaluations and recommendations for post-market surveillance of opioids
- Assisted in pre-submission meetings for Abbreviated New Drug Submissions (ANDS) in collaboration with the Pharmaceutical Drugs Directorate (PDD)
- Reviewed Risk Management Plans (RMPs) submitted as part of the ANDS process
- Acted as a mentor for new team members within the Scientific Section of Opioids
- Covered for the manager during absences, responding to urgent requests and ensuring smooth operation of the team
- Responded to out-of-the-blue requests, ADM requests, and media lines promptly and accurately
- Participated in and contributed to internal working groups and committees, ensuring comprehensive evaluations and recommendations
- Provided critical scientific and regulatory advice on the safety and effectiveness of marketed drugs, ensuring compliance with the Food and Drugs Act and Regulations
- Conducted supplementary research and literature reviews to support scientific evaluations
- Presented new potential safety concerns at risk prioritization meetings and provided recommendations for regulatory actions.
Scientific Project Coordinator (BI-2)
Health Products and Food Branch, Medical Devices Directorate, Bureau of Investigation Testing Authorization, Special Access Program and Post-Market Surveillance
Ottawa, Ontario
12.2021 - 07.2022
- Gathered, analyzed, interpreted, and reviewed scientific data from various sources to provide recommendations on the efficacy, benefits, and risks related to medical devices
- Analyzed and interpreted scientific data supplied by stakeholders to ensure consistency, accuracy, and compliance with the Medical Device Regulations
- Participated in drafting risk assessments for sensitive topics within the Medical Device Directorate
- Provided scientific and regulatory advice and recommendations to senior evaluators and stakeholders
- Reviewed and provided recommendations on Foreign Risk Notifications (FRN), Annual Summary Reports (ASR), and incident reports related to medical devices
- Maintained awareness of trends and research related to medical devices through scientific literature, foreign agencies notifications, and other sources for potential safety risks
- Provided input and responses to inquiries from stakeholders regarding amendments to the Medical Device Regulations.
Research Epidemiologist
Centre Intégré de Santé et des Services Sociaux de l'Outaouais (CISSSO), COVID Outbreak Management
Gatineau, Québec
05.2021 - 12.2021
- Entered laboratory results of COVID positive cases into the provincial system
- Interviewed patients to determine their period of contagiousness and isolation dates
- Sent formal emails to patients informing them of their results and isolation period
- Followed up on positive cases in various Long-Term Care Nursing Homes, Intermediate Resources, Private Seniors' Residences, and Hospitals
- Created a tracking system to monitor positive cases in facilities
- Reported outbreaks and attended meetings with Heads of Infection Prevention and Control to assess facility statuses
- Stayed updated with announcements and changes made by the Minister.
Quality Control Analyst
L'OREAL CANADA, Chemistry and Raw Material Laboratories
Montréal, Québec
05.2021 - 10.2021
- Ensured the conformity of finished products before release on the Canadian market
- Applied Good Manufacturing Practices (GMP) and regulations in product fabrication
- Performed and coordinated quality control activities such as pH, alkalinity, acidity, viscosity, fluorescence, IR, and evaluation of content in H2O2, thiol, etc
- Verified the identity and quality of raw materials provided by suppliers to ensure compliance with company guidelines
- Performed audits and inspections of equipment
- Reported flaws, non-compliance notices, and blocked pallets as needed
- Adjusted manufacturing protocols according to the chemical composition of raw materials to ensure final product compliance
- Participated and assisted in daily meetings
- Entered data using SAP and released products on the market.
Research Assistant/Student
Université de Montréal, Dr. Stéphane Roy Laboratory
Montréal, Québec
09.2018 - 12.2020
- Interpreted data of next-generation RNA sequencing: gene set enrichment analysis and pathway analysis with GSEA, DAVID, PANTHER, Reactome, DiRE, and EnrichR
- Conducted biological assays such as real-time polymerase chain reaction (qPCR), reverse transcription (rt-qPCR), RNA/DNA/protein isolation, Western blot, in-situ hybridization
- Conducted immunostaining by immunohistochemistry (immunofluorescence) and tissue staining with hematoxylin and eosin (H&E), beta-galactosidase, Crystal violet, and victoria blue
- Adhered to laboratory safety procedures in accordance with Division santé et sécurité au travail de la Direction de la prévention et de la sécurité (DPS-SST)
- Participated in the Canadian Council of Animal Care (CCAC) program and maintained a CCAC Certificate of good animal practice
- Drafted scientific reports, protocols, instructions, and manuscripts for scientific papers
- Provided support to intern students by training and teaching requisite procedures, protocols, methods, and techniques, and trained them in safety regulations, disposal of hazardous substances, and the safe use of equipment.
Teaching Assistant
Université de Montréal, Faculty of Medicine, Department of Biochemistry
Montréal, Québec
09.2019 - 09.2020
- Taught concepts of molecular biology to Biomedical and Biochemistry undergraduate students
- Trained students in various databases for searching scientific articles
- Taught techniques for interpreting, analyzing, and recognizing limitations in scientific articles
- Supervised students in the laboratory and set priorities to meet project and laboratory deadlines
- Implemented after-class tutoring programs and prepared materials for tutorial sections
- Evaluated student laboratory reports and scientific language, teaching techniques to improve their reports.
Customer Service Representative
ThermoFisher Scientific Supply Centre, Université de Montréal
Montréal, Québec
09.2018 - 07.2020
- Ensured inventory was properly merchandized and organized within the Supply Center
- Provided remote and onsite customer service
- Managed receipt, storage, and distribution of various supplies and product orders
- Gathered and shared customers' feedback with the company
- Promoted the company's products.
Research Fellow
Institut Armand-Frappier, Dr. Patrick Labonté's Laboratory
Laval, Québec
05.2017 - 06.2017
- Studied cell culture techniques and plasmid transfection on Huh7, and HepG2 lineages
- Analyzed autophagy by confocal microscopy and Western Blot techniques
- Designed and conducted experiments to meet study objectives
- Participated in discussions at team meetings, presented results, and discussed limitations and further research
- Prepared scientific reports on experiments, results, and conclusions
- Maintained clean and organized work areas and adhered to safety regulations.
Education
MASTER OF SCIENCE (M.Sc), 07/2021 - BIOCHEMISTRY AND MOLECULAR MEDICINE, SPECIALIZATION IN MOLECULAR GENETICS
UNIVERSITÉ DE MONTRÉAL
BACHELOR OF SCIENCE (B.Sc), 05/2018 - BIOCHEMISTRY AND MOLECULAR MEDICINE
UNIVERSITÉ DE MONTRÉAL
Skills
- Advanced research skills
- Coaching and training
- Protocol development
- Written and verbal communication
- Advance understanding of the Food and Drugs Act, the Controlled Drugs and Substances Act, the Medical Device Regulations and the Food and Drug Regulations
- Data Interpretation
- Critical Thinking and Judgment
Awards
- Recipient of the 2019-2020 Faculté des Études Supérieures et Postdoctorales (FESP) Excellence Award
- Recipient of the 2023 ADM Award for Excellence of the Health Products and Food Branch for Contribution to the Improvement of the Health of Canadians
Timeline
Acting Scientific Evaluator (BI-04)
Health Products and Food Branch, Marketed Health Products Directorate, Marketed Pharmaceuticals Bureau, Scientific Section of Opioids
11.2023 - 03.2024
Scientific Evaluator (BI-03)
Health Products and Food Branch, Marketed Health Products Directorate, Marketed Pharmaceuticals Bureau, Scientific Section of Opioids
07.2022 - Current
Scientific Project Coordinator (BI-2)
Health Products and Food Branch, Medical Devices Directorate, Bureau of Investigation Testing Authorization, Special Access Program and Post-Market Surveillance
12.2021 - 07.2022
Research Epidemiologist
Centre Intégré de Santé et des Services Sociaux de l'Outaouais (CISSSO), COVID Outbreak Management
05.2021 - 12.2021
Quality Control Analyst
L'OREAL CANADA, Chemistry and Raw Material Laboratories
05.2021 - 10.2021
Teaching Assistant
Université de Montréal, Faculty of Medicine, Department of Biochemistry
09.2019 - 09.2020
Research Assistant/Student
Université de Montréal, Dr. Stéphane Roy Laboratory
09.2018 - 12.2020
Customer Service Representative
ThermoFisher Scientific Supply Centre, Université de Montréal
09.2018 - 07.2020
Research Fellow
Institut Armand-Frappier, Dr. Patrick Labonté's Laboratory
05.2017 - 06.2017
MASTER OF SCIENCE (M.Sc), 07/2021 - BIOCHEMISTRY AND MOLECULAR MEDICINE, SPECIALIZATION IN MOLECULAR GENETICS
UNIVERSITÉ DE MONTRÉAL
BACHELOR OF SCIENCE (B.Sc), 05/2018 - BIOCHEMISTRY AND MOLECULAR MEDICINE
UNIVERSITÉ DE MONTRÉAL
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