A
KATE COLE-EMUZE
**********@*****.***
Unit 304
Waco,TX 76067
SUMMARY
Seasoned pharmacovigilance/drug safety professional with 18+ years of industry experience with major pharmaceutical organizations. Strong background in clinical pharmacology and patient medication therapy management. Patient service-oriented Pharmacist with Doctor of Pharmacy degree and advanced certification in Pharmacist Immunization Delivery, adept at managing pharmacovigilance processes, ranging from ICSR data collection and analysis of medical safety documents to the development and implementation of SOP and CA plans.
SKILLS
Individual and Aggregate Reporting (PBRER/PSUR, PADER, ICSR, DSUR, SSUR)
Oracle Argus, Safety Database, Basic SQL
Veeva Vault CDOCS/RIM
Medical Narrative and Review
GCP/GVP
MedDRA Coding
Case Processing
Signal Management
Risk Management
KPIs/KCIs
Therapeutic Areas – Oncology, Cardiovascular, Infectious Diseases
Drug utilization review skills
Strong decision-making, oral and written communication abilities
Ability to monitor and assess the outcome of drug therapies and interpret laboratory and other diagnostics parameters.
EXPERIENCE
SENIOR PHARMACOVIGILANCE/SAFETY MANAGER
NOV 2021 TO PRESENT - GIOMAX SOLUTIONS – CONTRACT
Responsible for the Clinical Safety strategy for assigned products throughout all stages of development and/or when on the market, including implementation and communication of the strategy at the project team/governance level.
Responsible for the continued safety assessment, evaluation and risk management of products or product groups in various stages of clinical development and/or the post-marketing setting.
Responsible for continuous efficient evaluation of adverse event and all other safety information in order to predict and manage the safety profile of compounds in clinical development and marketed products through identifying the need for update to reference safety information and drive proactive implementation of risk management initiatives in accordance with global regulatory requirements.
Responsible for consistent communication of safety topics across all regulatory safety documents, e.g., Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs), and Development Safety Update Reports (DSURs). for assigned product(s)/programs(s).
Proactively evaluates the clinical implications of safety data from pre-clinical studies, clinical studies, literature and other information sources in order to predict / establish the safety profile of compounds in clinical development and post approval.
Provides expertise to the medical content of the safety specification, pharmacovigilance plan and risk minimization activities in the core RMP.
Provides input on cross-functional ad-hoc teams set up to address urgent and important safety issues.
Involved in all safety surveillance activities, may include medical review of individual safety cases (providing medical expertise and judgement), signal detection, evaluation for all products in area or responsibility.
Sets the strategy for routine signal management activities.
Presents the results of data evaluation with the Surveillance Team and/or appropriate key stakeholders, e.g., Patient Safety VP TA, QPPV/Deputy QPPV.
Collaborates effectively in cross-functional and cross-cultural project teams and environments, and work with external providers.
WALMART
AUG 2023 TO DATE - STAFF PHARMACIST
Marlin,TX
Administered vaccines to immunize patients against communicable diseases.
Discussed over-the-counter medication and equipment options to help patients deal with individual symptoms.
Analyzed prescribing trends to monitor patient compliance and prevent excessive usage.
Improved drug inventory management procedures to reduce waste and eliminate backorders or overstock.
Checked prescriptions for appropriate dosage, drug interactions or allergies before dispensing medications.
Collaborated with physicians to provide patients with high quality and cost-effective medications.
Received and verified daily incoming drug inventories, reported discrepancies and logged items into inventory system.
Advised patients on potential drug interactions and side effects, proper dose timing and medication storage.
Created new customer profiles and updated information in pharmacy computer systems.
Obtained experience in the connexus cash register system and cash management procedures.
Secured drugs against theft, loss or mismanagement by setting and enforcing effective procedures.
Ensured compliance with strict health, industry, and organizational regulations.
Ensured prescribed therapies were safe and effective for the patient's current condition by reviewing prescribed dosages and medications.
Conducted drug utilization reviews, drug interventions and therapy management.
Communicated with all customers and staff in pleasant and professional manner.
Achieved and maintained customer satisfaction and retention by adhering to Walmart 10 foot rule and going way and beyond the call of duty using Moments of Care guidelines.
Verified patient data and billing information.
Maintained drug inventory levels by ordering necessary medications and supplies and verifying deliveries against purchase orders.
Increased staff's pharmaceutical knowledge through training.
Provided review, processing, filling, and dispensing of over 300+ prescriptions daily.
Communicated the potential issues and reactions of specific medications for patients ranging from children to geriatrics.
Implemented best practices, ensuring compliance with strict company regulations, policies and procedures.
Entered new patient profiles and prescriptions into medication input Connexus software system.
WALMART
PHARMACY MANAGER (INTERIM)
March 2021 to July 2023 Garland, Texas
Ensure compliance with company and legal policies, procedures, and regulations
Ensure confidentiality of information, documentation, and assigned records as required
Encourage and drive sales in both OTC department and pharmacy
Provide supervision and development opportunities for associates in pharmacy department
Enforce and provide direction and guidance to associates on excellent customer service approaches and techniques to ensure customer needs, complaints, and issues are successfully resolved within company guidelines and standards
Communicate clear expectations regarding quality of care and patient safety
Use relevant business metrics ad reports to measure, monitor, and improve performance
Provide performance review and evaluation of pharmacy associates
Utilize auditing processes to identify compliance issues and implement process for improvement
Partner with store associates and management t execute pharmacy services and processes
Ensure customers receive the level of service that builds their trust and confidence
Establish, coordinate and maintain the work schedule to best serve the needs of the customer and in accordance with budgeted payroll hours
Implement strategies to attract and maintain a highly skilled and engaged workforce
Implement strategies to meet operational and financial goals for the pharmacy department
Monitor and evaluate the quality and effectiveness of patient care provided by pharmacy staff
Communicate regulatory changes and requirements
Solicit information on a customer’s medical history to give appropriate medical advice and counseling.
Provide clinical services, such as medication therapy management (MTM), drug information, immunization.
WALMART
SEP 2009 – MAR 2020 - STAFF PHARMACIST
September 2009 to March 2021
Administered vaccines to immunize patients against communicable diseases.
Discussed over-the-counter medication and equipment options to help patients deal with individual symptoms.
Analyzed prescribing trends to monitor patient compliance and prevent excessive usage.
Improved drug inventory management procedures to reduce waste and eliminate backorders or overstock.
Checked prescriptions for appropriate dosage, drug interactions or allergies before dispensing medications.
Collaborated with physicians to provide patients with high quality and cost-effective medications.
Received and verified daily incoming drug inventories, reported discrepancies and logged items into inventory system.
Advised patients on potential drug interactions and side effects, proper dose timing and medication storage.
Created new customer profiles and updated information in pharmacy computer systems.
Obtained experience in the connexus cash register system and cash management procedures.
Secured drugs against theft, loss or mismanagement by setting and enforcing effective procedures.
Ensured compliance with strict health, industry, and organizational regulations.
Ensured prescribed therapies were safe and effective for the patient's current condition by reviewing prescribed dosages and medications.
Conducted drug utilization reviews, drug interventions and therapy management.
Communicated with all customers and staff in pleasant and professional manner.
Achieved and maintained customer satisfaction and retention by adhering to Walmart 10 foot rule and going way and beyond the call of duty using Moments of Care guidelines.
Verified patient data and billing information.
Maintained drug inventory levels by ordering necessary medications and supplies and verifying deliveries against purchase orders.
Increased staff's pharmaceutical knowledge through training.
Provided review, processing, filling, and dispensing of over 300+ prescriptions daily.
Communicated the potential issues and reactions of specific medications for patients ranging from children to geriatrics.
Implemented best practices, ensuring compliance with strict company regulations, policies and procedures.
Entered new patient profiles and prescriptions into medication input Connexus software system.
WALMART
ASSISTANT PHARMACY MANAGER
April 2008 to September 2009
Monitored and evaluated the quality and effectiveness of patient care and therapy provided by pharmacy staff
Verified prescriptions for appropriate dosage, drug interactions and/ or allergies before dispensing medications.
Collaborated with physicians to provide patients with high quality and cost-effective medications.
Implemented best practices, ensuring compliance with strict company regulations, policies and procedures.
CVS
PHARMACIST LEAD
Apr 2004 to Apr 2008
Precisely processed up to 1000 prescriptions on high volume days with 100% accuracy.
Checked prescriptions for appropriate dosage, drug interactions or allergies before dispensing medications.
Advised patients on potential drug interactions and side effects, proper dose timing and medication storage.
Ensured prescribed therapies were safe and effective for the patient's current condition by reviewing prescribed dosages and medications.
Secured drugs against theft, loss or mismanagement by setting and enforcing effective procedures.
Strictly maintained customer and patient confidentially
EDUCATION AND TRAINING
Doctor of Pharmacy
University of Florida
Gainesville, FL
Bachelor of Science: Pharmacy
University of Benin
Nigeria
APhA Immunization Certificate
American Pharmacists Association
Issued April 2014 No Expiration Date