Experience

Academy of Applied Pharmaceutical Sciences

• Canada
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Program Advisor, Clinical Research Drug Safety and Pharmacovigilance Diploma Program

  • Jan 2022 - Present

  Overview and support the program within AAPS campuses and affiliated institutions.Development and designing of in-class and online educational curriculum for Canadian and US program classes.Development of the organizational and operational plans, grants, contracts, and procedures to attain program goals.

• Instructor - Clinical Research Drug Safety and Pharmacovigilance

  • Feb 2020 - Dec 2021

  Managing daily teaching and training. Developing a variety of Clinical Research, Regulatory, and PV courses.Providing practical coaching and mentoring students on study protocols and SOP development.Creating and updating the content of educational materials and modules, to reflect current standards and regulations.



CannTrust

• Regulatory Scientist - Clinical Trials

  • Apr 2019 - Nov 2019

  Managed clinical development programs from design to study report. Developed and overviewed clinical sections of regulatory documents (IND, NDS, IB etc.).Prepared safety update reports, clinical overviews and summaries.Designed studies to meet desired clinical endpoints and with appropriate methods and measurements, ensuring alignment with regulatory guidelines for specific indications.Attended and contributed at regulatory meetings with FDA, Health Canada, and EMA. Managed clinical development programs from design to study report. Developed and overviewed clinical sections of regulatory documents (IND, NDS, IB etc.).Prepared safety update reports, clinical overviews and summaries.Designed studies to meet desired clinical endpoints and with appropriate methods and measurements, ensuring alignment with regulatory guidelines for specific indications.Attended and contributed at regulatory meetings with FDA, Health Canada, and EMA.



BioPharma Services Inc.

• Canada
• Pharmaceutical Manufacturing
• 200 - 300 Employee

• Clinical Research Scientist

  • May 2017 - May 2019

  Designed and prepared Phase I to IV (first in human, human abuse liability) and BE and BA study protocols, ICFs (literature review, discussion for preparing proof of concept).Provided clinical and/or scientific quality checks (internal review) for the documents (reports, protocols, IBs, letters to regulatory agencies etc.).Reviewed non-clinical data in preparation to transition to the first in human clinical trial.Interacted efficiently with PK scientists and biostatisticians to make sure that the studydesign is in line with the most updated regulatory and scientific requirements.Interacted with IRBs with respect to protocols, ICFs and other documents as required.



Inflamax Research Inc.

• Clinical Research Coordinator

  • Aug 2015 - May 2017

  Conducted Phase I-II clinical studies.Recruited, screened, and coordinated healthy volunteers and patients with allergy, COPD and asthma (medical history, IP dosing, health check and adverse events monitoring).Performed quality functions and executed quality programs to support CRO processes.Assisted in the development of department SOPs, Equipment Binders, templates.

• Pharmacy Associate

  • Jun 2016 - Jan 2017

  Managed Investigational Product (receipt, dispensing, labeling, accountability and destruction and/or return to sponsor).Participated in clinical project initiation, study IP monitoring visits, communicated with sponsors and all training planned for IP handling.



Adam Clinical Trials

• Clinical Research Coordinator

  • Sep 2014 - Sep 2015

  Conducted Phase III and IV clinical studies sponsored by AstraZeneca, Astellas Pharma and Novartis in patients with COPD, cardiovascular diseases, diabetes mellitus, and overactive bladder. Conducted Phase III and IV clinical studies sponsored by AstraZeneca, Astellas Pharma and Novartis in patients with COPD, cardiovascular diseases, diabetes mellitus, and overactive bladder.



RAPID Staffing Solutions

• Business Development Manager

  • May 2014 - May 2015



Pfizer

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Country manager /Product Manager

  • Jan 2012 - Jan 2014

  Built and led the country and commercial operations for the organization in ArmeniaResponsible for market entry approach and the commercial presence in all therapeutic areas (manage registration of 3 new products)Identified, developed and executed appropriate reimbursement strategies involving all key stakeholdersCreated development and training plans for direct reports (7 direct reports)Increased market share of retail sales from 1.45% till 2.32% within 2 years achieving growth in 2013 net sales of Pfizer products by 35%



Institute of Cardiology

• Research associate

  • Sep 2008 - Dec 2011

  Developed innovative research questions, study protocols, grant/funding proposals, and coordinated REB approvalsPerformed medical screening, recruited and monitored health and care of subjectsParticipated in source data collection and CRF completionCoordinate bioequivalence and pharmacokinetic studies in accordance with GCP guidelines and the study protocols Managed regulatory documents and completed study documents, in accordance with SOPs Developed innovative research questions, study protocols, grant/funding proposals, and coordinated REB approvalsPerformed medical screening, recruited and monitored health and care of subjectsParticipated in source data collection and CRF completionCoordinate bioequivalence and pharmacokinetic studies in accordance with GCP guidelines and the study protocols Managed regulatory documents and completed study documents, in accordance with SOPs



Military Hospital

• Head of Pharmacy

  • Jan 2009 - Dec 2010



Pfizer

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Product Manager/Medical representative

  • Mar 2005 - Dec 2008

  Developed planning, launch and ongoing product sustainingBuilt relationships and made effective calls with healthcare professionals and hospital administration Increased the market share of Liprimar® (Atorvastatin) from 15% to 55% in 3 years. Achieved 160% of budget realization in 2007 Developed planning, launch and ongoing product sustainingBuilt relationships and made effective calls with healthcare professionals and hospital administration Increased the market share of Liprimar® (Atorvastatin) from 15% to 55% in 3 years. Achieved 160% of budget realization in 2007



Yerevan State Medical University after M. Heratsi

• Higher Education
• 100 - 200 Employee

• PhD Student

  • Sep 2005 - Sep 2008

  PhD Thesis: “Evaluation of changes of daily BP and arterial stiffness characteristics under the treatment of different antihypertensive medications”. (Supervisor: prof. Romen Boroyan) PhD Thesis: “Evaluation of changes of daily BP and arterial stiffness characteristics under the treatment of different antihypertensive medications”. (Supervisor: prof. Romen Boroyan)



ARMENIAN MEDICAL ASSOCIATION

• Board Member

  • 2003 - 2008

  Youth secretary Youth secretary