Summary
Overview
Work History
Education
Skills
Certification
Software
Interests
Timeline
Manager

Jaspreet Singh

An Adept Strategist, Deep Thinker & An Embracer Of Change
Michigan Based,MI

Summary

Jaspreet Singh is a seasoned business strategist and a highly motivated collaborative leader with over 14 years of excellent track record in integrating, implementing and executing independent strategies across Pharmacovigilance operations. Effective leader and problem-solver dedicated to streamlining operations to decrease costs and promote organizational efficiency. Highly committed with hardworking mentality to maintain quality of services and products. Innovative and goal-oriented Lean-Six-Sigma Green Belt champion skilled at spearheading strategic business processes & change management which ensured an adherence to worldwide regulations & impeccable quality at all levels of Safety operations (upstream and downstream). Excellent customer relations aptitude and well-known for creating positive workplace culture and high-performing teams.

Overview

1
1
Certification
9
9
years of post-secondary education
13
13
years of professional experience

Work History

Manager

Syneos Health
Royal Oak, M
02.2020 - Current
  • 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 Million Dollar of year-over-year savings- Total department size 1400 with an annual revenue of 120 Million.
  • Establishing Business Pricing Model within SPVG department in conjunction with cross functional stakeholders (Project Directors, Executive Directors) to ensure the functional strategic priorities are aligned with overarching corporate strategic imperative.
  • Increased Monthly financial reporting including completion of forecasting/backlog to ascertain resourcing demand and capacity pressures for top 20 customers (revenue stamp $65 Million) over rolling 12 month period.
  • Maximized productivity (utilization index) by 5 basis points month over month to yield a $400k of direct revenue into SPVG department.
  • Leading weekly strategic/operational huddles for tackling inconsistencies/anomalies within corporate Global Resource Management and drafting uniform solution among cross functional stakeholders (financial, project managers, Safety oversight Directors) on backlog and utilization alignment. Goal is to reduce the variance to less than 25% between forecasting and actual revenue.

Sr. Global Safety Operations Specialist

Syneos Health
Ann Arbor, MI
07.2018 - 02.2020
  • Handled the management and accountability for the entire pharmacovigilance proposal process (including drafting and strategically evaluating RFPs & RFIs) in collaboration with Business Development, Corporate partners and SPVG Executive leadership. Budget value range from $25,000 through 10 Million.
  • Launched (Six Sigma Process change) interactive Dashboard reflecting macro and micro insights including fiscal health (awards/losses/CO/CNF). This enabled shorter cycle-time and increased data accuracy to 99.9%.
  • Value strategy (including value proposition) and carving competitive landscape for large FSP and SSA clients. Engaged key strategy team members and Safety Project Leads for Hand-over meetings.
  • Attended defense meetings and prepared bespoke slide decks in alignment with project scope.
  • Facilitated SPVG Annual Gross Profit percentage (GP%) target creation by working with the SPVG FSP & Operational Delivery team and ensured an appropriate understanding of the factors that drive GP% for the SPVG units are reflected in the budget tools.
  • 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.
  • Designed SPVG PreAward pitch deck with compelling storyboard & engaging graphics reflecting unique value proposition Routinely interacted & liaised with Pharmacovigilance Operations team (QPPV, Signal Detection, and Literature & Program Delivery) & mapped out short term and long term solution strategies.
  • Demonstrated respect, friendliness and willingness to help wherever needed

Senior PVG Project Lead

Syneos Health
Ann Arbor, MI
06.2013 - 07.2018
  • 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 for off-shore team. Delivered in excess of 99.2% quality on case processing KPIs.
  • Provided strategic input (10-12 projects), including providing subject matter expertise for Safety Services in the planning and setup of projects, including costing, budgeting, resourcing, workflow and process design and analysis. Proactively notified the Project Director of scope creep or out of scope operational delivery units for the assigned projects. Balanced labor & cost impacts.
  • Seamless drafted 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.
  • Strategic liaising with business development, alliance management, contracts and proposals development, project management, and clinical management to achieve project goals.
  • Embraced and adapted to change management across Safety operations- driven by internal or external forces
  • Facilitated 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 SAE worksheets reporting and adding corresponding data into safety databases by advising them of appropriate term selection based on latest MedDRA coding. This enhanced reporting suggested preferred term by 20 %.
  • Reviewed all medical and drug terminologies according to project specific coding conventions, Package Insert, Investigator Brochure and Company Code Data Sheet. Successfully managed SDEA for Global PV transition project.
  • Expanded and improved services to support consistent regulatory reporting compliance (US CIRB, EMA, EUDV, PMDA) at or above 99% in less than 3 months.
  • Spearheaded in-Process Quality Review Outlook integrated feedback form while replacing paper based Client enforced QC form. This enabled validation users to provide valuable and constructive feedback to Data Entry users in real time- transformed into PV hub (Global CP QC metrics portal)
  • Contributed towards detecting any quality signals (QI) (at process & operational level) and implementing CAPA to drive quality & compliance

Clinical Project Manager

Michigan Medicine, University of Michigan Health System
Ann Arbor, MI
05.2012 - 06.2013
  • Led and managed diverse portfolio of Transplant and Oncology clinical studies (4-5 projects): Coordinated kick-off meetings with sponsors, assisted in study initiation protocols, reviewed pre-defined timelines for timely completion of SAE submission, patient screening and enrollment, informed consent documentation and query management.
  • Ensured compliance in data entry in Inform and Rave EDC platform.
  • Managed cross functional Hospital strategic partners, including Principal Investigators, for seamless study execution within budget, on-time and in alignment with Sponsor protocol.
  • Reviewed patient recruitment strategies and recommended solutions and change to medical director/principal investigator

Clinical Safety Operations Manager

Beaumont Hospital
Royal Oak, MI
04.2011 - 09.2011
  • Conducted investigations on medical device incidents & performed new medical device/product evaluations.
  • Maintained understanding of evolving local and international regulations for medical device vigilance reporting and risk management.
  • Responsible for effective and efficient development of safety management plan.
  • Effectively maintained safety database and corresponding entry guidelines, including accurate entry of data and assurance of quality.
  • Reconciled SAEs in accordance with project specific guidelines.
  • Develop and monitor Compliance with equipment preventive maintenance schedules. Timely issue of CAPA and risk mitigation strategies.
  • Used critical thinking to break down problems, evaluate solutions and make decisions

Principal Research Associate

Detroit Medical Center
Detroit, MI
08.2008 - 09.2010
  • Ensured safe functioning and handling of medical equipment and devices- Anesthesia machines, physiological monitors, electrosurgical units (program budget $5M- $15M, Team Size 2-10).
  • Successfully managed a QA program (RCA & CAPA) for a major supplier of Cardiac Rhythm Devices.
  • Sub-projects ranged from battery environment and design feasibility testing, transportation testing, data communications failure investigation, and multiple levels of verification and validation support.
  • Actively listened to customers' (Medtronic/Biotronik/St. Jude Medical) requests, confirming full understanding before addressing concerns

Associate Production Engineer

Ranbaxy Pharma
Mohali, Punjab
04.2006 - 11.2007
  • QA/QC of production of formulations of multiple drugs- bulk and individual.
  • Performed tasks of assisting pharmaceutical engineers in designing packing and labeling of medicines.
  • Directed 6-person production team to introduce efficient methods of production
  • Created engineering documentation, including manufacturing processes, equipment specifications and change notices

Education

Master of Science - Clinical Research

Eastern Michigan University
Ypsilanti, MI
05.2017 - 01.2020

Master of Science - Biomedical Engineering

Wayne State University
Detroit, MI
01.2008 - 01.2011

Bachelor of Engineering - Biotechnology

UIET (Panjab University)
Detroit, MI
05.2003 - 01.2007

Skills

    Diplomatic Communication

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Certification

Lean Six Sigma Green Belt

Software

MS Office

SQL

Argus Safety

ArisG

Medidata Rave

E2B/XML import export

MS Project

AWS Cloud

Interests

Artificial Intelligence & it's deep impact on Homo Sapiens

Cloud and Website Designing

Reading: Non Fiction

Traveling

Cooking

Timeline

Manager

Syneos Health
02.2020 - Current

Sr. Global Safety Operations Specialist

Syneos Health
07.2018 - 02.2020

Master of Science - Clinical Research

Eastern Michigan University
05.2017 - 01.2020

Senior PVG Project Lead

Syneos Health
06.2013 - 07.2018

Clinical Project Manager

Michigan Medicine, University of Michigan Health System
05.2012 - 06.2013

Clinical Safety Operations Manager

Beaumont Hospital
04.2011 - 09.2011

Principal Research Associate

Detroit Medical Center
08.2008 - 09.2010

Master of Science - Biomedical Engineering

Wayne State University
01.2008 - 01.2011

Associate Production Engineer

Ranbaxy Pharma
04.2006 - 11.2007

Bachelor of Engineering - Biotechnology

UIET (Panjab University)
05.2003 - 01.2007

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Jaspreet SinghAn Adept Strategist, Deep Thinker & An Embracer Of Change