Objective

To secure a position in Pharmacovigilance / Clinical Research department in an Associate, Specialist, Coordinator or Analyst role

Professional Profile

** ***** ** ********** ** Clinical Research Field

Postgraduate diploma in Clinical Research, Drug Safety and Pharmacovigilance, 2016-2017, Canada

Practical knowledge of ICH-GCP guidelines, FDA regulations and standards governing clinical research

Comprehensive understanding of Phases I-IV clinical research, clinical trial organization and monitoring

Possess analytical and technical skills in designing and implementing all aspects of source documentation and data collection, entering, cleaning and management

Experienced in writing clinical study protocols, Informed Consent Forms (ICFs), Case Report Forms (CRF/eCRF) and Standard Operating Procedures (SOPs)

Trained in coding of adverse events /medical histories/concomitant disease using MedDRA dictionary, fluent in medical terminology

Performed reviewing, processing, submitting and timely reporting of Adverse Events (AEs) and Serious Adverse Events (SAEs) to regulatory authorities in compliance with global pharmacovigilance regulations

Trained on Tri-Council Policy Statement (TCPS2) for the ethical conduct of research involving humans

Experienced in subject screening and recruitment per Inclusion/Exclusion Criteria of protocol

Skilled in coordinating clinical work with little or no supervision and multi-tasking working

Proven skills working in a fast-paced environment while working under pressure to meet deadlines

Strong interpersonal communication, negotiation and problem-solving skills

Outstanding ability to set priorities, focused with excellent attention to details

Experienced in working with statistical software(SPSS)

Work Experience

Clinical Research Coordinator, Cliantha Research Inc. (Inflamax Research Inc.), Mississauga, ON April 2018-Present

• Conducting clinical and study procedures as per study protocols, ensuring minimal deviations and proper tracking and reporting when deviations occur

• Involving in potential subject screening, recruitment and coordination of patient visits as per study protocols

• Participating in subject information /ICF process/obtaining informed consent form and verifying medical charts

• Monitoring study activities to ensure compliance with protocols and regulatory requirements

• Assisting in design, development, implementation and coordination of all aspects of data collection, source documentation and CRF transcription as per protocol, SOPs and ICH/GCP guidelines

• Communicating with the PI, Sub-I and conducting REB submission

• Participating in AEs/SAEs evaluation and reporting

• Preparing for and support QA audits and sponsor monitoring visits

Pharmacovigilance and Medical Information Assistant, Nestle Skin Health (Galderma Canada Inc.), Toronto, ON May-December 2017

• Involved in verifying, processing, documenting and reporting Adverse Events (AEs)

• Evaluated and recorded data related to AE cases

• Made decisions to triage, report and submit reportable AEs to Health Canada in compliance with timelines and per SOPs

• Organized all accurate and complete information of AE cases for Health Canada auditing

• Participated in quality assurance and control of related reports and documents

• Provided activities in deviation investigations and implemented effective CAPAs

Clinical Research Project Manager, Clinical Research Associate and Clinical Research Coordinator, Dr. Shariati Hospital (Internationally Accredited) Tehran, Iran; 2002- 2013

Managed and monitored all administrative functions of clinical research implementation and all related protocols

Prepared study and clinical proposal designs and wrote clinical proposals for ethics evaluation and funding purposes

Monitored patients’ conditions and ensured that individual Adverse Event Case Reports were evaluated, investigated and disseminated appropriately to internal staff

Screened subjects and recruited them based on Inclusion/Exclusion Criteria of clinical research protocol

Completed domestic Adverse Drug Reactions (ADRs) /Adverse Events (AEs) and Serious Adverse Events (SAEs) forms online and submitted them in accordance to Regulatory Authorities

Followed rules and regulations to ensure patients safety during clinical trials and identified the corrective actions

Executed and monitored clinical research projects and presented final scientific reports

Advised patients family on disease prevention and provided counseling and support to patients and their families on lifestyle issues

Provided highest quality care to patients and conducted follow-up activities

Collected recorded and maintained patient information, such as medical history, reports and examination results

Collected patient histories and filled out related questionnaire, requesting laboratory tests and other diagnostic procedures

Maintained, updated and managed databases which included data collection, verification, coding, merging and analysis

Volunteer Experience

Admin Support, Toronto General Hospital, Toronto, ON; April-December 2015

• Maintained medical documentation, ensured confidential documents were stored securely

Auditor, St. Joseph s Health Centre, Toronto, ON; May-December 2015

• Conducted audits throughout the hospital

Education

Post Graduate Diploma in Clinical Research, Drug Safety and Pharmacovigilance, Academy of Applied Pharmaceutical Sciences, Toronto, ON 2017

Modules include: GCP and GVP inspections and audits, global clinical research and pharmacovigilance, clinical project management, clinical data management, clinical study protocol, clinical research SOP development, clinical pharmacology and clinical safety assessment, clinical study and safety reporting activity, ethics in clinical research and drug safety

Master s Degree in Public Health, Tehran University of Medical Sciences, Tehran, Iran 2010

(Canadian equivalency performed)

Doctorate Degree in Medicine, Tehran Azad University of Medical Sciences, Tehran, Iran 1999

Internship in: Pediatrics, Surgery, Internal Medicine, Gynecology and Obstetrics, Cardiology,

Ophthalmology, Psychiatric, Neurology, Infectious Diseases, Health, Dermatology and ENT

Publications Available upon request.

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