Summary
Overview
Work History
Education
Accomplishments
Timeline
Generic

Qusai F. Shakir MD

Pharmacovigilance Clinical Scientist
Bakersfield,CA

Summary

Pharmacovigilance Clinical Scientist focused on compliance for ICSRs within the US. Utilizing medical knowledge and clinical experience to ensure safety reports are compliant by FDA regulations.

Overview

8
8
years of professional experience
17
17
years of post-secondary education

Work History

Pharmacovigilance Clinical Scientist - ICSR Mgmt

Roche, Genentech
05.2024 - Current
  • Develop enhanced proficiency in navigating and utilizing the Roche global safety database, LSMV.
  • Mentor onbaording colleagues, fostering a culture of continuous learning and professional development.
  • Co-lead Therapeutic areas 3 and 5 in ensuring excellent quality and compliance standards by our GVP vendor, TCS.
  • Support the team overseeing source data quality check to ensure compliance of MAP and GVP vendors
  • Support oversight of multiple quality and compliance teams including global preganancy monitoring, Literature QC, Manufacturer courtesy letter quality team and Non-PV QC.

Market Research & Patient Support Programs Analyst

Genentech
11.2022 - 05.2024
  • Communicate and resolve logistical issues between vendors and Pharmacovigilance Operations and Innovations (O&I)department that occur during oversight activities in order to ensure positive metrics for our global key performance indicators.
  • Create a process for appropriate storage and organization of patient safety documents and minutes between the local safety unit and MAP vendors to ensure easy accessibility during internal audits or health authority inspections.
  • Improvement of compliance in service provider Case Transmission Verification(CTV) and Source Data Quality Check (SDQC). After discovering a gap in our oversight of a type of source data not being reported as required, I revamped the documentation process for all programs.
  • 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 Pharmacovigilance Clinical team and leadership. This lead to the service providers developing proficiency in safety data reporting ability.
  • Perform MAP Lead activities - After ensuring the successful closeout of deviations for 6 months, I was in charge of overseeing a remediation for a process deviation requiring healthcare professional expertise.
  • 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 Adverse Event 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 by consolidating multiple trackers into a single tracker. This improved communication between the MAP team and O&I team resulted in a reduction of 12 hours worked per week.

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
  • 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


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

M.D. -

Caribbean Medical University
05.2001 - 10.2018

Bachelor of Science - Pre-Medicine

Kasturba Medical College International Center
07.2006 - 2008.06

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

Pharmacovigilance Clinical Scientist - ICSR Mgmt

Roche, Genentech
05.2024 - Current

Market Research & Patient Support Programs Analyst

Genentech
11.2022 - 05.2024

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 - 2008.06

M.D. -

Caribbean Medical University
05.2001 - 10.2018

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Qusai F. Shakir MDPharmacovigilance Clinical Scientist