Rana Shash

• Led pharmacovigilance activities for multiple global pharmaceutical companies, supporting local and global safety requirements
• Successfully executed three company acquisitions while maintaining uninterrupted pharmacovigilance operations and operational continuity.
• Led associated pharmacovigilance data migration projects, ensuring data integrity, validation, reconciliation, and regulatory compliance.
• Partnered with global teams across Canada, the United States, France, Belgium, Spain, and other international affiliates.
• Acted as Project Lead between clients, Regulatory Affairs, Medical Affairs, Quality Assurance, vendors, and operational teams, facilitating cross-functional collaboration and resolution of complex operational and compliance issues

Pharmacovigilance

• Managed end-to-end domestic and foreign Individual Case Safety Reports (ICSRs).
• Ensured compliance with Health Canada regulations, client agreements, and global PV requirements.
• Screened Canada Vigilance and worldwide literature.
• Prepared aggregate safety reports.
• Supported local safety surveillance activities and ongoing monitoring of product safety information.
• Participated in medical review and quality review of safety cases, supporting data quality, completeness, and patient safety.

Medical Information & Patient Programs

• Responded to medical information requests from healthcare professionals and patients.
• Supported Patient Support Programs.
• Assisted with reimbursement and patient access pathways.
• Managed product complaints and health safety inquiries.
• Conducted follow-up communications with healthcare professionals and patients.

Quality & Compliance

• Developed SOPs and Work Instructions.
• Developed CAPAs.
• Participated in internal and external audits.
• Supported inspection readiness.
• Worked closely with Quality Assurance.
• Ensured quality management system compliance.
• Administered pharmacovigilance training programs to internal staff and external partners.
• Supported vendor oversight activities and ensured compliance with local pharmacovigilance requirements.

Leadership & Projects

• Managed multiple concurrent pharmacovigilance projects,prioritizing regulatory, quality, operational, and patient safety requirements.
• Coordinated international project teams.
• Led acquisitions and pharmacovigilance system transitions.
• Oversaw data migration planning and execution.
• Delivered pharmacovigilance training.
• Identified operational improvements that enhanced compliance and efficiency.
• Built effective relationships with internal and external stakeholders to resolve challenges and support consistent implementation of pharmacovigilance processes.

• Contributed to the development, revision, and implementation of regulatory standards, policies, guidelines, processes, and systems supporting cannabis regulatory activities.
• Drafted Standard Operating Procedures (SOPs), registration applications, templates, and guidance documents in accordance with the Access to Cannabis for Medical Purposes Regulations.
• Collaborated in the development, testing, and implementation of a data management system to compile and manage regulatory information.
• Participated in multidisciplinary meetings, committees, and working groups addressing operational, policy, scientific, and regulatory issues.
• Reviewed SOPs and documentation related to compliance and enforcement activities.
• Supported process improvement initiatives and contributed to the implementation of regulatory frameworks and quality processes.
• Worked collaboratively with cross-functional stakeholders to ensure consistent application of regulatory requirements and procedures.

• Managed renal transplant and hemodialysis patients (adult and pediatric).
• Provided patient and caregiver education on medications, including post-transplant discharge counseling across diverse educational and cultural backgrounds.
• Designed and implemented individualized pharmaceutical care plans, including Dose Administration Aid services.
• Assessed patient and caregiver compliance and provided adherence aids when appropriate.
• Provided repeat prescription services and organized medication supply for post-transplant patients.
• Participated in outpatient clinics, monitored laboratory data and patient parameters, and assessed adverse drug reactions.
• Documented interventions, adverse drug reactions, and medication errors for quality improvement.
• Liaised with medical and nursing staff regarding medications and patient care.
• Assisted in evidence-based drug selection and patient monitoring.
• Evaluated, prevented, and managed drug-related problems.
• Participated in multidisciplinary laboratory review rounds.
• Reviewed medication orders for appropriateness, interactions, allergies, and duplication.
• Maintained accurate medication histories and patient documentation.
• Ensured adherence to formulary policies and recommended alternatives.
• Managed ward stock and conducted medication safety inspections.
• Dispensed medications and calculated dosages for pediatric, renal, and hepatic patients.