Qusai F. Shakir MD

• Coordinates with the appropriate support functions to execute
QA/QC, metrics
tracking and SP communications for his/her assigned SP.
Job Duties/Responsibilities:
Oversight / Project Management
• Understands the vendor management framework set by the Head of SP PV Oversight and SP
PV Oversight Manager
and translates the requirements into reporting deliverables (e.g., QA/QC metrics, action items,
etc.)
• Works with the Vendor Lead on the oversight of GVP and MAP SPs
o Supports with the Vendor Lead on all operations performed, including the implementation of
policies/procedures that ensure efficient and compliant operations
o Ensures quality and PV requirements are met in accordance with contractual obligations.
• Facilitates and participates in SP oversight activities such as SP meetings.
o Develops agenda and facilitates meetings with SP
o Tracks statuses for critical milestones and metrics
o Creates action items and follow-ups on action items
o Appropriately escalates to SP PV Oversight Manager and Vendor Lead as required
• Communicates closely with local cross functional teams within USDS to ensure the
appropriate level of support is
achieved to ensure oversight.
• Determines priorities and resource load balancing to manage backlogs, action items, and
business as usual.
• Leads, coordinates, and collates QC error rates, QC metrics, trends, and gaps for the SP PV
Oversight Manager and
Vendor Lead.
• Leads or assists in the tracking and investigation of case processing related metrics (e.g., late
case investigation)
including compliance related issues set by the vendor management strategy.
• Understands the PV environment and works with Vendor Lead and SP PV Oversight Manager
to identify SP
compliance risks.
Monitoring Performance

• Monitors SP compliance to applicable SOPs and Key Performance Indicators as detailed in
the Service Agreement
and global/local requirements.
• Oversees Corrective and Preventative Actions by the SP, as required.
• Supports SP PV Oversight Manager and Vendor Lead during audits and inspections.
Issue / Risk Management
• Acts as a day-to-day point of contact with USDS SPs and ensures strong relationships and
communication are built
between GNE and the SP.
o Acts as a point of inquiry for any questions/concerns raised by the SP with appropriate
resolution or
escalation by Roche/GNE
o Provides regular feedback on performance and quality checks to the SP working together with
SP PV
Oversight Manager and Vendor lead.
o Working together with the SP PV Oversight Manager and Vendor Lead, communicates any
processes or
procedural changes
o Escalates any critical decisions or discussions to the Vendor Lead and SP PV Oversight
Manager
• Provides support to SP PV Oversight Manager and Vendor Lead by answering questions on
Vendor Management
reports and deliverables.
• Escalates SP risks to the Vendor Lead and SP PV Oversight Manager as required.
• Actively identifies process improvement opportunities, gaps, and risks and communicates to
SP PV Oversight
Manager and Vendor Lead to support continuous quality improvement.
Competencies Identified for Success:
● Exemplifies strong, dynamic leadership and demonstrates decisiveness and appropriate
decision-making abilities as
demonstrated by systematic gathering of information, appropriately assessing the complexity of
issues, and
prioritization of tasks in a timely manner within the scope of responsibility and escalates
identified issues to
management in a timely fashion.
● Works effectively, independently, and collaboratively as a team member with global
stakeholders and external
business partners,
● Strong organizational skills, detail oriented and adapts in a fast paced, changing environment

● Demonstrates ownership, initiative, accountability, strong organizational skills, and is solution
oriented Excellent
communication skills, both written and verbal
● Ability to actively exchange knowledge and ideas
● Able to identify potential business gaps and leads in the development and implementation of
process solutions
● Able to handle the pressure associated with and adapts to a fast-paced, changing
environment
● Demonstrates ownership, initiative, accountability, strong organizational skills, and is solution
oriented
● Inspires others to do their best work by offering encouragement and support Maintains
personal and corporate
Integrity
Education, Experience, and Other Requirements:
• Life sciences degree BSc minimum (or >10 years’ experience in a similar role)
• 5+ years in pharmacovigilance or compliance-related role required
• Advanced analytic and computer skills (e.g., Microsoft Excel, other data visualization tools)
preferred
• Medical terminology experience preferred
• Writing experience; science/medical writing highly desirable
• Able to travel as per business needs required
• Able to be agile and adapt to shifting priorities and needs
• Able to be flexible to accommodate differences in vendor time zones

• 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
• Appraised inventory levels and ordered new merchandise to keep quantities well-stocked.
• Recruited, hired and trained initial personnel, working to establish key internal functions and outline scope of positions for new organization.
• Trained new employees on proper protocols and customer service standards.
• Strategically managed resources, milestones and budgets, saving $1500 per month in expenses.
• Delivered business strategy and developed systems and procedures to improve operational quality and team efficiency.

• 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
• Coordinate with the R&D teams to prepare media, reagents, and buffers to execute cell extract production, establish a platform for bacterial growth, and stimulate test reactions
• 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
• Partner with technicians and scientists to maintain health and safety of laboratory operations, ensuring instrument maintenance, record keeping, and inventory controls are efficient and compliant

• Attended daily rounds which improved my understanding of medical needs of the community.
• Viewed and discussed patient interactions with attending physicians.
• Discussed assessment, plan and future management of patients.
• Participated in case discussions, grand rounds and noon conference presentations.

• Collected, recorded and maintained patient medical history, reports and examination results.
• Administered specialized treatment for multiple patients daily.
• Created treatment plans balancing medical expertise, patient goals and individual compliance levels.
• Explained procedures and discussed test results or prescribed treatments with patients.
• Provided and managed direct patient care by conducting physical examinations, evaluations and assessments to determine diagnosis.

• Assisted in calling patients and gathering data pertaining to the side effects and quality of life measurements for post cystectomy patients with neobladder.
• Scheduled appointments with test subjects over phone and through email.
• Performed statistical, qualitative and quantitative analysis.
• Worked with principal investigators to coordinate qualitative research.
• Exceeded goals through effective task prioritization and great work ethic.