Natasha Paul
Clinical Pharmacist/Drug Safety Specialist/Pharmacovigilance Associate
Edmonton,AB
Summary
Pharmacovigilance professional with experience focused on ICSR processing and regulatory submissions. Skilled in adverse event triage, MedDRA coding, and narrative generation. Known for high attention to detail and ensuring compliance with international pharmacovigilance standards to promote drug safety.
Experienced in completing clinical reviews, counseling patients and supporting physicians with information about appropriate dosages and protocols. Well-versed in medication contraindications, interactions and side effects.
Overview
1
1
year of professional experience
2012
2012
years of post-secondary education
3
3
Certifications
3
3
Languages
Work History
Clinical Pharmacist
Meds N Care Pharmacy
06.2024 - Current
- Developed strong relationships with healthcare providers, facilitating communication and collaboration for better patient care coordination.
- Evaluated medication regimens for complex patients, identifying potential drug interactions and devising alternative treatment strategies when necessary.
- Collaborated with interdisciplinary healthcare teams for optimal patient care and improved treatment outcomes.
- Improved patient outcomes by providing medication therapy management and comprehensive pharmaceutical care to diverse patient populations.
- Educated patients on proper medication use and adherence, leading to improved health outcomes and decreased hospital readmissions.
- Educated patients on possible drug interactions, potential side effects, and optimal methods of administration.
- Enhanced drug safety by participating in pharmaceutical research and staying informed about drug recalls and safety alerts.
- Contributed to healthcare team decisions by providing expert pharmaceutical advice.
- Enhanced patient safety by conducting detailed medication therapy management reviews.
Drug Safety Specialist (Remotely)
MediPharmSolutions
06.2024 - Current
- Assisted in the preparation of regulatory submissions, including new drug applications (NDAs) and amendments.
- Collaborated with regulatory affairs teams to ensure that ICSRs are accurately prepared and submitted to regulatory authorities.
- Identified trends in expected and unexpected adverse events to support risk management strategies.
- Reviewed incoming adverse event reports to determine causality and prioritize follow-up actions.
- Conducted periodic reviews of MedDRA coding practices and updates to ensure adherence to industry standards and regulatory requirements.
- Provided expert recommendations on drug dictionary usage and terminology to support safety evaluations and regulatory compliance.
- Managed the revision and update of narratives in response to new information or changes in regulatory standards.
- Provided training and support to team members on best practices for managing reporting timelines and meeting deadlines.
- Collaborated with IT and software development teams to troubleshoot and resolve issues related to E2B transmission systems.
- Analyzed trends and patterns in medication error data to identify potential safety signals and inform risk management strategies.
Education
Post-Graduate Diploma - Project Management
Bachelor of Pharmacy - undefined
Skills
Expertise in processing Individual Case Safety Reports (ICSRs)
Strong command of MedDRA coding and hierarchical structures
Preparation and submission of periodic safety reports (PSURs)
Management of adverse event followup and data clarification
Knowledge of pharmacovigilance regulations (FDA, EMA, MHRA)
Experience with safety databases (Oracle Argus, ARISg)
Causality assessment and seriousness determination
Quality assurance of case processing and submission
Proficiency in narrative generation for ICSRs
Strong collaboration with regulatory and medical teams
Patient counseling on drugs and medical devices
Adverse drug reaction monitoring
Clinical documentation
Certification
Advanced Drug Safety and Pharmacovigilance certification, 01/01/24
Timeline
Clinical Pharmacist - Meds N Care Pharmacy
06.2024 - Current
Drug Safety Specialist (Remotely) - MediPharmSolutions
06.2024 - Current
Punjab Technical University - Bachelor of Pharmacy,
Humber College - Post-Graduate Diploma, Project Management