Name variants:
Hetal Sheth
Last updated May 19, 2024
Contact Information
Last Update
Jul 10, 2022
Email
he**@gmail.com, he**@yahoo.com
Location
New Brunswick, NJ
Company
Workplace

Colleagues
Work History
Global Program Manager
4280 Hacienda Dr, Pleasanton, CA 94588
Overall global delivery, quality and growth across global, enterprise Life Sciences clients
Strategic relationship with key business and IT stakeholders across multiple life sciences Vault...
from May 2017
Client Services Director - Life Sciences
500 west Burr Blvd, Teaneck, NJ
Providing account management, consulting services, specifically in the Supply Chain excellence, Serialization (SAP ATTP), SAP ERP and Manufacturing portfolios
Management Consulting & A...
Mar 2014 — May 2017
Executive Program Mgr, Global Delivery and Services
1 Research Way, Princeton, NJ 08540
Engagement and Global Program Management - Responsible for all aspects of Global Serialization Program Management that includes governance, alignment of project objectives and finance contro...
Jan 2013 — Feb 2014
Associate Director Safety Evaluation Risk Assessment
200 Kimball Dr, Parsippany, NJ 07054
Feb 1, 2012 — Jul 1, 2013
Management Consultant - Commercial Portfolio, Life Sciences
Engagement and business partner relationship management across all levels of the organization. Providing account oversight and overall governance of Commercial Sales and Marketing portfolio ...
Jan 2011 — Dec 2012
Consultant - Solution Manager and Project Manager
2000 Galloping Hill Rd, Kenilworth, NJ 07033
Overall responsibility for management and delivery of a request management SharePoint 2007 solution for Discovery and Preclinical Sciences using Agile SCRUM Methodologies.
Aug 2010 — Jan 2011
Senior Manager, Regulatory
Driving process improvements, and leading establishment of technical capabilities within Regulatory Operations
2009 — Jul 2010
Program Manager, Regulatory Affairs
Instrumental in establishing a program management office (PMO) within the Regulatory Affairs (RA) group and managing the overall portfolio of ongoing and upcoming projects. Maintained PMO da...
2008 — 2009
Manager of Pharmacovigilance Research and Medical Safety Expert
200 Kimball Dr, Parsippany, NJ 07054
Oct 1, 2003 — Oct 1, 2011
Project Manager, Global Project Management
Whippany, NJ
Successfully led cross-functional teams to deliver several ISI Software Implementation projects, spanning initial analysis, design, collaboration, deployment, coordination and client service...
2003 — 2008
Technical Consultant
New York, NY
Designed, developed and deployed several internal software solutions within the backpanel engineering department. Java/ J2EE Programming
Extensively interfaced with IBM Global Services to ...
2000 — 2003
Pharmacovigilance Consultant
Provide medical expertise and input, on assigned safety sections of aggregate safety reports including Periodic Safety Update Reports (PSURs) and Development Safety Update Reports (DSURs) Re...
Associate Director, Safety Information Management
Jersey City, NJ
Pharmacovigilance Risk Management
Author submission documents including US Periodic Reports and literature review section of DSUR
Participate in various task forces created to streamline ...
Clinical Safety Associate
formation per corporate and departmental Standard Operating Procedures (SOPs).
Collected required clinically relevant information for SAE reporting from suppliers.
Actively obtained follo...
Physician Assistant
Practiced as a Physician Assistant/ clinical practitioner in the Department of Medicine with Beth Israel Medical Center in which my responsibilities included examining, diagnosing and treat...
Education
2000 — 2002
1995 — 1999
upto
Occupations
Executive
Program Director
Partner
Director
Operations Manager
Chief Executive
Skills
Cross Functional Team Leadership
Program Management
Sdlc
Project Management
Pharmaceutical Industry
Management
Sharepoint
Validation
Pmo
Change Management
Crm
Analysis
Agile Methodologies
Document Management
Scrum
21 Cfr Part 11
Management Consulting
Lifesciences
Drug Development
Rim
Regulatory Submissions
Business Relationship Management
Ectd
Software Development Life Cycle
Veeva
Regulatory Compliance
Program Delivery Management
Serialization
Dscsa
Supply Chain
Dqsa
Gs1
Strategic Partnerships
Account Management
Strategic Financial Planning
Program Budgeting
Risk Management
Consulting
Author Pv Related
Allied Health
Suppliers
Books
Member of A Team
Safety Engineering
Data Entry
Glc
Acting
Trend Analysis
Clinical Research
Safety Management Systems
Psurs
Procedural
Mentoring
Finance
Streams
Docs
Medical Records
Business Administration
Nda
Co Authored
Literature
Examining
Windows Xp
Assessment
Detection
Dictionaries
Briefing
Financial Statements
Coaching
Jamaica
Aggregate
Continuous Improvement
Sop
Composed
Committees
Auditing
Pfizer
Powerpoint
Publications
Signal
Epidemiology
Collaborative
Execution
Otc
Literature Reviews
Implementation Planning
Cros
Implement Eu Gvp
Sae
Capas
Consumer
Escalation
System
Education
Healthcare
Safety Statements
Training Material
Radio Access Network
Gvp
Reports
Strategy
Branding
Strategies
Medicine
Microsoft Excel
Product Reviews
Training
Point of Contact
Patient
Ctd
Subject Matter Expert
Group Setting
Scheduling
Documentation
Aggregate Safety Data
Informatics
Quality Control
Research
Reporting
Basics
Task Force
Call Centers
Investigation
Information Management
Surveillance
Inspection
Written
General Practitioner
Hospitals
Rx
Jersey
Yahoo
C
Management System
Fix Protocol
Conventions
St. John
Adverse Events
Debate
Product Safety
Data Collection
Communication
Physician Assistants
Respond To Health
Business Alignment
Efficacy
Sheets
Dossiers
Advertising
European Union
Sheet
User Requirements
Meddra
Novartis
Safety
Summaries
Author
Argus
Risk Assessment
Marketing
Queries
Develop and Implement
Mining
Forest
Documentum
Contractual Agreements
Drug Safety
Pharmacy
Re Engineering
Case Report Forms
Responsibility
Internal Audit
Regulations
Labelling
Rmp
Arisg
Israel
Executive Management
Portfolio
Switch
Lotus Notes
Microsoft Exchange
New York
Affiliates
Treating
Team Performance
Process Improvement
Bridge Inspection
Data Quality
Information Exchange
Compliance
Outlook
Pharmacovigilance
Microsoft Word
Develop
Business Process
Fluency
Safety Meetings
Nursing
Core Data
Due Diligence
Summarize
Psur
Meetings
Legal Review
Templates
Employee Health
Fda
Recruiting
Evaluation
Coordinated
Conclusions
Mhra
Databases