Qusai F. Shakir MD
MAP Safety Analyst
Bakersfield,CA
Summary
Pharmacovigilance analyst and Innovative, bilingual medical doctor and with 1+ years experience. Comprehensive communication and organizational aptitude recognized for driving enrollment and testing for clinical studies at the Valley Fever Institute, CA and leading multiple presentations at regional medical conferences on immunogenetics studies in diverse populations. Drives team success with expertise in data review, reporting and specimen handling.
Overview
7
7
years of professional experience
2
2
years of post-secondary education
Work History
MAP Safety Analyst
Genentech
11.2022 - Current
- Communicate and resolve logistical issues between vendors and PV Operations and Innovations department that occur during oversight activities in order to ensure regulatory compliance and positive metrics for our global key performance indicator reports. Escalate appropriately to the vendor lead and Head of MAP and Safety Partnering.
- Ensure appropriate documentation of minutes and other communication between the local safety unit and MAP vendors.
- Conduct oversight of Case Transmission Verification (CTV) and Source Data Quality Check (SDQC) for Market Research and Patient Support Programs (MAP) service providers for Access Solutions and Medvantx.
- Facilitate communications between case processing team and vendors to fulfill follow up requests for additional medically relevant information in a timely manner to avoid late cases. Worked with the case processing team and provided feedback in order to improve the follow up process in providing consistent information which lowered the average time taken to complete case followups.
- Subject matter expert for the enhancement and update of MAP vendor training materials by facilitating content approval by PV clinical and leadership. This lead to the service providers developing proficiency in safety data reporting ability.
- Perform MAP lead activities by overseeing end to end process deviation close outs for corrective actions requiring extensive remediation.
- Quality oversight of safety data from customer relationship management (CRM) sources and ensure reporting requirements are adhered to. Appropriately escalated deficiencies and ensured the understanding of AE reporting by all CRM owners.
- Conduct oversight of and streamlined the process of Digital Customer Engagement and Listening Activities (DiCELA) CTV and Patient Facing Roles (PFR) CTV.
Clinical Research Associate
Kern Medical Center and Valley Fever Institute
10.2019 - 10.2022
- Administered data collection and analysis for an immunogenetics study with valley fever for 54 patients, with a comprehensive review and reporting of patient medical histories and bio-specimens
- Customized SOPs’ for immunogenetics studies to manage epidemiological, clinical, general laboratory, microbiological, serological, histopathological, and radiographic testing modalities
- Researched Community-Acquired Pneumonia (CAP) in Endemic Areas (SAnds-PPC), and completed the sub-study to evaluate host gene signature-based Diagnostics in persons Aged > / = 14 years
- Presented research and findings at regional medical gatherings on the causes and effects of valley fever and relative impacts of peritonitis, anemia, diabetes, and meningeal disorders
- Orchestrate the recruiting and interviewing of 100+ human subjects for scientific studies and educate participants on enrollment, process, potential risks, side effects, and anticipated outcomes
- Perform clinical observations at medical inpatient facilities and infectious disease clinics and assemble with peers twice daily to optimize collaborative learning and sharing of best practices
CFO and Senior Operations Manager
Wasco True Value Hardware LLC
05.2017 - 10.2022
- Collaborated with over 20 local businesses and community agencies to establish sales initiatives and marketing campaigns that increased referrals by over 25% in less than 6 months
- Directed the day-to-day operations, sales, marketing, human resources, and training for 13 employees, achieving an average of $30,000.00 in weekly revenue
- Trained new employees on proper protocols and customer service standards.
Education
Bachelor of Science - Pre-Medicine
Kasturba Medical College International Center
07.2006 - 06.2008
M.D. -
Caribbean Medical University
Curaçao 05.2001 -
Skills
Accomplishments
- A Rare Case of Uncomplicated Intrathoracic Stomach Due to Congenital Short Esophagus in a 10 week-old Female, Southern San Joaquin Valley Research Forum 2nd Annual Regional Gathering, 2021. This case study highlighted the incidental finding of complete hiatal hernia in a 2 month old female. This condition wasn’t found due to clinical signs or symptoms but rather a worried mother who was hearing an odd sound resembling that of a heartbeat from an ultrasound. The patient was subsequently ruled out for surgical or medical intervention
- Isavuconazole in Rescue Therapy for Disseminated Non-Meningeal and Meningeal Coccidioidomycosis, Southern San Joaquin Valley Research Forum Inaugural Regional Gathering, 2020. Study on the novel drug Isavuconazole and its effectiveness on 41 patients with refractory Coccidioidomycosis
- Cavitary Coccidioidomycosis and Diabetes Southern San Joaquin Valley Research Forum Inaugural Regional Gathering, 2020. Study on 110 patients with valley fever and diabetes who also present with cavitary disease.
- Coccidioidomycosis Peritonitis: A Review of 11 Cases, Southern San Joaquin Valley Research Forum Inaugural Regional Gathering, 2020. Evaluating 11 cases of patients with valley fever presenting with peritonitis
- Anemia: Signs and symptoms of Anemia, Burhani Medical Idara Preventative Care Clinic, 2019.Increasing awareness of anemia among the local and international community, and the investigation, management, and treatment of the various causes
- Smart Eating, Fakhri Masjid, 2018. How our physiology changes in response to intermittent fasting during the month of Ramadan and the effect of foods and portion sizes and their relation to macromolecules and fasting preparation
Timeline
MAP Safety Analyst
Genentech
11.2022 - Current
Clinical Research Associate
Kern Medical Center and Valley Fever Institute
10.2019 - 10.2022
CFO and Senior Operations Manager
Wasco True Value Hardware LLC
05.2017 - 10.2022
Bachelor of Science - Pre-Medicine
Kasturba Medical College International Center
07.2006 - 06.2008
M.D. -
Caribbean Medical University
05.2001 -
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