Jaspreet Singh, Pmp®, Cssbb™ Email & Phone Number

-Provide expert project and strategic advisement to the Biotech and Pharma partners, focusing on delivering pharmacovigilance projects for their entire product lifecycle (phase 1 through IV)- Lead a global project management team, ensuring alignment with organizational goals and objectives.- Oversee technical and process change management initiatives, driving efficiencies and cost savings of approximately 250k.- Collaborate with cross-functional teams to ensure compliance with regulatory requirements and industry standards.- Develop and implement strategies to support revenue growth and business expansion, aligning with key strategic imperatives.- Foster a culture of continuous improvement, innovation, and excellence within the project management function.- Serve as a trusted advisor to senior leadership, providing insights and recommendations to inform decision-making processes.- Maintain awareness of industry trends, emerging technologies (adapting and leveraging Artificial Intelligence and LLR/LLM), and best practices to drive innovation and competitive advantage.

-Under the executive leadership (VP & EVP), implementing a comprehensive strategic blueprint within the Global SPVG department with a potential to provide a realization of 2-3 Million Dollar of year-over-year savings. Total department size 800 with an annual revenue of 100 Million.-Responsible for complete overhaul and streamlining of the entire SPVG resource management- resource allocation, demand and capacity pressures, FTE forecasting and budget assessment. Total financial impact of $60 Million and 700 FTEs. Optimizing the entire resourcing strategy with proper change management controls.-Leading weekly strategic/operational huddles for tackling inconsistencies/anomalies within the corporate Global Resource Management and drafting a uniform solution among cross functional stakeholders (financial, project managers, Safety oversight Directors) on the backlog and utilization alignment. Goal is to reduce the variance to less than 25% between the forecasting and actual revenue.

Ann Arbor, Michigan

-Established value stream mapping for the SPVG PreAward team. Increased cycle time of processing RFPs/RFI by staggering 15%. Optimized proposal process (including drafting and strategically evaluating RFPs & RFIs). Budget value range from $25,000 through 10 Million.-Collaborated closely with SPVG leadership and carved bespoke value strategy and competitive landscape for large FSP and SSA clients. Used critical thinking to assess the unique value proposition which resulted in 10% growth sales above and over the annual target of $30 Mil.-Facilitated SPVG Annual Gross Profit percentage (GP%) target creation by working with the SPVG FSP & Operational Delivery team.-Presented monthly growth metrics (Sales, Revenue, RFP Pipeline-volume and dollar amount) to leadership team on macro and micro elements of PreAward RFPs for pipeline expansion and customer growth.

Ann Arbor, Michigan

-Successfully managed FSP PVG operations team (team size 70-110) in 3 different regions (US-EU-APAC). Exceeded baseline Key performance Metrics by 15-20% for over 6 months in a row for off-shore team.-Utilized professionally recognized tools for planning and management of scope, timeline, resources, and ensured that minimum (or forecasted) hours are used for tasks. Proactively notified the Project Director of scope creep or out of scope operational delivery units for the assigned projects. Operational management of 10-12 projects at one time.-Identified best practices and participated in process improvement initiatives in conjunction with the global SPVG leadership plan and project deliverables.-Seamless drafting of various Safety study plans in accordance with Standard Operating Procedures and/or client-scoped process. Complied with all controlled document requirements and other requirements to ensure quality deliverables.-Developed and maintained relationships with customers in alignment with their assigned projects. Collaborated with business leads for business development, alliance management, contracts and proposals development, project management, and clinical management to achieve project goals. Ensured that individual project targets and client needs are met, services are provided with the highest quality standards, and policies and procedures are followed. >Contributed to change management across and within the SPVG department:>Facilitated a dynamic strategy to roll out Internal Corrections Forms which improved quality by 15% on month to month basis.- Coordinated with data management and clinical sites on discrepancies in the SAE worksheets reporting and adding corresponding data into the safety databases by advising them of the appropriate term selection based on the latest MedDRA coding. This enhanced reporting the suggested preferred term by 20 %.

Ann Arbor, Michigan

-Lead and managed diverse portfolio of clinical study trials. Coordinated the kick-off meetings with sponsors, reviewed pre-defined timelines for timely completion of SAE submission, Patient screening and enrollment, informed consent documentation and query management. Ensured compliance in reporting requirements and tracking of AE’s, SAE’s, and ADR’s. Reviewed clinical trial protocols, bioequivalence study protocols and provide inputs. Handled the Investigational new drug supplies and its labels and proper storage. Performed quality control of clinical reports by utilizing study specific procedures.-Ensured that the Trial Master files are complete. Collaborated with Clinical Operations, Regulatory Affairs, CRA’s; Quality and Medical Affairs. Managed multiple duties, tasks and assignments within time constraints/deadlines while establishing and maintaining effective working relationships with stakeholders. Tracked and maintained "Late Uploads and Submissions" as it relates to AE cases and request for or send out Deviation Reports as required.-Reviewed and processed adverse events reported by investigators and patients, submitting it to IRB, FDA for regulatory compliance. Study files, medical record review, data extraction, completion of case report forms (CRF’s) including the EDC using Medidata Rave and InForm. Acted as a liaison with other departments and maintaining compliance with regulatory requirements.

Royal Oak

-Conducted investigations on medical device incidents and reporting any serious adverse event to FDA. Prepared safety report as per schedule and to report to regulatory authorities. Performed new medical device/product evaluations and give process improvement recommendations. Maintained an understanding of evolving local and international regulations for medical device vigilance reporting and risk management. Using the Complaint and CAPA Management Systems: Track Wise.-Reviewed patient care equipment safety alerts and recall notices and take appropriate actions as needed. Coordinated and participated in requests for budget control, equipment acquisition planning. Supported clinical study planning, implementation, and reporting activities for investigational devices.-Project management (planning, requirements definition, risk analysis, budget, resources, and schedules) utilizing cross-functional teams (direct and indirect). Was responsible for effective and efficient development of the safety management plan. Effectively maintained the safety database and corresponding entry guidelines, including accurate entry of data and assurance of quality.

Greater Detroit Area

• Ensured the safe functioning and handling of medical equipment and devices- Anesthesia machines, physiological monitors, electrosurgical units (program budget $5M- $15M, Team Size 2-10).• Supported Quality Assurance regarding non-conforming commodities, root cause analysis, and CAPA projects; Successfully managed a program for a major supplier of Cardiac Rhythm Devices, consisting of over 16 parallel sub-projects. Sub-projects ranged from battery environment and design feasibility testing, transportation testing, data communications failure investigation, and multiple levels of verification and validation support. • Process optimization/improvement tools that helped teams create more efficient workflows. Statistical analysis tools that enable teams to evaluate data more effectively. Improve an existing business process and profitability by identifying defect opportunities. Studied the Information management processes. Value streamed the process based on the lean operation principles.

Greater Detroit Area

Studied the Information management processes in placeStudied the various management database systemsValue streamed the process based on the lean operation principlesEliminated the wastes involved in the management of information systemStandardized the work process through the implementation of fool proof systemSix Sigma Class project-Implementing the DMAIC approach

India

Controlled the production of various Drugs, Quality check of the Chemical Content of various formulations. Preparing worksheets for any discrepancies in the production output.Involved in the production of different therapeutic drugs- Anti-Infective, Inflammation & Respiratory, Metabolic Diseases.Actively evaluated options for acquiring new technology platforms to develop differentiated high margin products.Contributed to new NDDR research program meant to treat certain infectious diseases

Chandigarh Area, India

Computer aided Drug Designing for Bird Flu (Neuraminidases protein). Study and usage of basic tools - BLAST, PDB, SAVS, NCI to identify the correct protein and ligand structures.Usage of custom based software's like Ligbuilder, Auto dock, HEX, Modeler etc. to carry out proper interaction between protein and its ligand along with minimization of energy.

Chandigarh Area, India

Performed Gel Filtration chromatography for purification of proteins.Worked with western blotting and ELISA test for the presence of protein.Maintained Good Manufacturing Practices (GMP) standard by strictly adhering to SOP's

Master'S Degree, Clinical Research Administration

Activities and Societies: ACRP, DIA, SOCRA

M.S, Biomedical Engineering

Activities and Societies: BMES, IEEE

B.E, Biotechnology 2003-2007