Reebu Jeffin
Ottawa,Canada
Summary
Accomplished Clinical Pharmacist with extensive expertise in pharmacovigilance and regulatory compliance. Demonstrated success in enhancing drug safety and efficacy through strong analytical skills and effective leadership. Proficient in navigating Health Canada and FDA guidelines, adept at resolving complex issues while ensuring clear communication. Committed to leveraging knowledge to improve patient outcomes and uphold compliance in a dynamic healthcare environment.
Overview
13
13
years of professional experience
Work History
Medical Coding Officer
Centre for Immunization Surveillance, Public Health Agency of Canada
10.2021 - Current
- Accurately and timely processing of Adverse Events Following Immunization reports, including initial reports, updates as well as data received through follow up requests
- Applying processing and coding instructions and prioritization as per latest version of Canadian Adverse Events Following Immunization Surveillance System processing user guide, meeting notes/OneNote, and task card instructions
- Review and resolve case related data issues, answering and resolving queries, reviewing of medical records, identifying errors in data by performing data review
- Proficient in handling patient details reviewing, coding, resolving discrepancies
- Contribute to the development, review, and maintenance of standard operating procedures and guidelines for the team
- Process Individual Case Safety Report as per applicable standard operating procedures including triage, duplicate Search, data entry, MedDRA coding, seriousness assessment, expectedness assessment, causality assessment and reportability assessment
- Proficient in Microsoft Office (Outlook, Word, Excel, and PowerPoint) and One Note
Operations Specialist
IQVIA
03.2021 - 09.2021
- Company Overview: Canada
- Adverse Events Following Immunization reports, Initial Case Safety Report processing for Health Canada and US Food and Drug Administration
- Processed safety data according to applicable regulations SOP and project requirements
- Firsthand experience in processing data from US Food and Drug Administration, Medicines, and Healthcare products Regulatory Agency (United Kingdom), Eudra Vigilance Web reporting tool (Europe)
- Experience in Seriousness assessment, labelling, Causality, Initial and Follow up
- Assessed expectedness based on the global and local Product Monograph
- Narrative writing for all adverse or other reportable events
- Performed case evaluation, causality, severity, and seriousness criteria
- Assisted in audit preparation/inspection
- Review patient information in the database and ensure accurate documentation as per client
- Canada
Clinical Pharmacist
Thumbay Hospital
12.2016 - 12.2019
- Company Overview: Ajman, U.A.E
- Assisted in clinical study team with the clinical/scientific conduct of clinical
- Implemented and interpreted grant management policies, ministerial standards, regulations, practices, and procedures
- Conducted information in person one on one coaching for final year university students
- Checked prescriptions for errors and made sure they are appropriate for patients
- Contributed to various interdepartmental working groups
- Provided advice and reported directly to the Pharmacy Director
- Promoted healthy communities by counselling patients and families
- Developed innovative health promotion resources
- Provided technical assistance/ coaching to new pharmacist on strategic planning, participatory evaluation, health promotion and active offers
- Ajman, U.A.E
Drug Analyst Officer
Julphar Gulf Pharmaceuticals
04.2012 - 08.2015
- Company Overview: Ras Al Khaimah UAE
- Ensured compliance with pharmacopeial standards and internal quality guidelines
- Conducted stability studies and validated analytical methods
- Maintained detailed documentation to uphold audit and regulatory readiness
- Participated in internal audits and supported external regulatory inspections
- Ras Al Khaimah UAE
Education
Policy Making and Briefing Notes -
GC Learning
01.2024
Policy Implementation Case Study: The 2030 Agenda for Sustainable Development -
GC Learning
01.2024
Regulatory Affairs Graduate Certificate -
Humber College
08.2023
Canadian Pharmacovigilance Regulation Certification -
Eu2P
08.2021
Pharmacovigilance Training -
CCRPS
02.2021
Bachelor of Pharmacy -
Tamil Nadu Dr. MGR Medical University
Tamil Nadu, India01.2009
Medical Device Establishment Licensing and Post market regulation -
Canada School of Public Service
GCP for Clinical Trials with Investigational Drugs and Medical Devices -
CITI Program
Clinical Trials: Good Clinical Practice Specialization -
Novartis Learning
Skills
- Analytical thinking
- Innovative leadership
- Pharmacovigilance knowledge
- Health Canada guidelines
- Understanding FDA Guidelines
- International Council for Harmonization guidelines
- Application of principles and standard operating procedures
- Facilitation skills
- Presentation skills
- Communication skills
- Interpersonal communication skills
- Creativity
- Strategic Problem Resolution
- Strategic planning
- Decision-making
- Financial management
- Human resources management
- Advising senior management
- Leadership
- Relationship management
- Effective oral communication
- Effective written communication
- Task prioritization
- Working under pressure
- Standard operating procedures
- Good Clinical Practices (GCP)
- Good Laboratory Practices (GLP)
- Good Manufacturing Practices (GMP)
Training
- Policy Making and Briefing Notes, 2024
- Policy Implementation Case Study: The 2030 Agenda for Sustainable Development, 2024
- Clinical Trials: Good Clinical Practice Specialization, Novartis Learning
References
References available upon request.
Timeline
Medical Coding Officer
Centre for Immunization Surveillance, Public Health Agency of Canada
10.2021 - Current
Operations Specialist
IQVIA
03.2021 - 09.2021
Clinical Pharmacist
Thumbay Hospital
12.2016 - 12.2019
Drug Analyst Officer
Julphar Gulf Pharmaceuticals
04.2012 - 08.2015
Policy Making and Briefing Notes -
GC Learning
Policy Implementation Case Study: The 2030 Agenda for Sustainable Development -
GC Learning
Regulatory Affairs Graduate Certificate -
Humber College
Canadian Pharmacovigilance Regulation Certification -
Eu2P
Pharmacovigilance Training -
CCRPS
Bachelor of Pharmacy -
Tamil Nadu Dr. MGR Medical University
Medical Device Establishment Licensing and Post market regulation -
Canada School of Public Service
GCP for Clinical Trials with Investigational Drugs and Medical Devices -
CITI Program
Clinical Trials: Good Clinical Practice Specialization -
Novartis Learning
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