Jackleen Hanna

- Collaborate in maintaining an efficient vigilance system in compliance with the Health Canada regulations and guidelines, participating in other Pharmacovigilance (PV) processes and ensuring appropriate contacts with internal and external stakeholders.

- Collect, pursue follow-up information to complete quality adverse event reports and transmit all local adverse events to Global Pharmacovigilance (GPV).
- Document and update case information into the PV safety database as as per Good Documentation Practices (GDPs).
- Analyze and process adverse events and safety reports with utmost quality and timeliness in accordance with Global and Local PV procedures.
- Respond to queries and requests from internal and external stakeholders.
- Evaluate domestic and foreign ICSRs (marketed and non-marketed drugs) for submission to Health Canada according to Canadian regulations and within prescribed timelines.
- Collaborate in developing and maintaining the local Pharmacovigilance standard operating procedures (SOPs), work instructions and job aids.
- Provide support in the Periodic Safety Report activities in accordance with Canadian regulations and corporate procedures.
- Support activities involving product launch, risk management plans, studies, safety queries, handling product alerts, and review of product monographs and protocols.
- Provide support in the maintenance of Canadian product list and reporting rules for PV database configuration.
- Support local literature review activities including oversight of the review performed by global vendors, maintaining lists of journals and products, and handling literature-related queries.
- Provide training and on-going support as well as perform quality assurance and quality control for work delegated to the global PV vendors (CPOC, i.e. Country PV Operating Center) and addressing issues.
- Provide support for Signal Detection and Local Safety Surveillance activities in accordance with regulatory and corporate requirements.
- Maintain current knowledge of all relevant local Pharmacovigilance regulations for Sanofi marketed products.
- Educate internal and external stakeholders on the implications of existing PV regulations and guidance documents along with local and global procedures and policies.
- Provide support in monitoring compliance with Canadian and foreign case management activities and implement corrective and preventative actions involving the PV team.
- Participate in the ongoing optimization of PV procedures as well as inter-departmental procedures affecting PV.
- Provide overall support to the PV team activities

As a pharmacovigilance coordinator my day to day tasks are:

- working on Sanofi products including ERT Medications (Myozyme, Cerezyme, Fabrazyme, Aldurazyme), Dupixent Freedom support program, caprelsa and Cablivi.

- Reviewing and reporting adverse events and product technical complaints within the required time frame (one business day).

- Reviewing documents (Post injection training reports, Reimbursement documents, Dupixent Dosage forms, Enrollment Forms) in both english and French recognizing and reporting adverse events(Scores, Off label).

- Initiating deviations investigation by communicating with the responsible departments to find out the root cause and CAPA.

- Responding to emails received from Sanofi to follow up on adverse events, sending faxes to health care practitioners as well as communicating with nurse case managers to follow up with patients regarding adverse events.

- Trained on Allergan products and PAH products reporting to help with those programs when needed.

- Transcribing voice messages received from nurses or pharmacists in both English and French.

- Completing the required trainings and meeting deadlines.

• Working on Allergan Cares Compassionate Use Program.

- Performing Welcome Calls in both english and French

- Assessing patient eligibility.

- Activating Nexgen Card for eligible patients

- Sending documentation to patient's pharmacies applying PPN procedures

- Reviewing enrollment forms and following up with health practitioners for missing information.

- Working in a team based environment where every one works hard to complete the process for patient's best benefit with meeting deadlines and making sure no delays in patient's access to medications.

- Handling escalations and exceptions.

• Working on Johnston Health Watch Specialty Care

- Reviewing Prior Authorization first time and renewal requests

- Communicating with patient support programs

- Performing welcome calls and applying PPN policy.

- Reimbursement Navigation

- Meeting KPIs

• Carried out day to day duties accurately and efficiently.
• Handled Inbound calls in both english and french to address customer inquiries and concerns.
• Served customers in a friendly, efficient manner following outlined steps of service.
• Actively listened to customers' requests, confirming full understanding before addressing concerns.
• Worked with refill team for scheduling deliveries for different programs.
• Document Reviews for Dupixent program
• Indexing incoming enrollment forms for all the programs
• Handling Forteo PSP Surveys
• Reporting Adverse drug events and products complaints
• Worked flexible shifts 8 am to 8 pm
• Worked in a team based environment

• Led research team on Scientific projects and successfully met all key milestones.
• Generated data models, performed analysis and helped produce reports outlining results.
• Wrote research papers, reports, reviews and summaries
• Performed research into study topics to increase knowledge and ability to provide valuable contributions.
• Collaborated with team members to initiate best practices to achieve organizational goals.
• Gathered and organized information for research purposes.
• Streamlined research processes to meet tight deadlines for multiple projects.
• Completed testing projects by deadline and under budget for company-wide initiatives.
• Worked on research projects for diabetes and Acute Lymphocytic Leukemia
• Published paper in international scientific journals

• Assisted patients in minimizing medical expenses by recommending generic alternative prescription medications.
• Processed prescriptions in busy pharmacy achieving decreased customer wait times and maintaining excellent customer satisfaction.
• Administered on-site immunizations to promote vaccination initiatives for wellness.
• Monitored ordering of pharmacy medication stock to maintain streamlined inventory and low overhead.
• Educated patients on possible drug interactions, potential side effects and optimal methods of administration.
• Reviewed patient medication profiles and medical records to screen for appropriate drug selection, dosing, contraindications, side effects and therapeutic outcomes.
• Evaluated patient histories to assess medication compliance and spot issues such as doctor shopping or excessive usage.
• Inspected drug storage sites, monitored drug supply expiration dates and verified proper supply levels.
• Achieved and maintained top customer satisfaction and retention by cultivating productive relationships with patients.
• Interviewed, hired and trained technicians and other support staff.
• Supervised and coached team of pharmacy technicians and trainees.
• Counseled patients on proper use of over-the-counter medications and explained potential side effects.
• Verified safety and accuracy of physician orders.
• Dispensed medications and communicated with prescribers regarding therapeutic incompatibilities.
• Supervised work of pharmacy clerk and technicians to optimize service quality and productivity.
• Assisted patients with over-the-counter medication recommendations and responded to questions concerning drug interactions.