Hi, I’m
Preety Mishra
Ashland,MA
Summary
Offering solid foundation in analytical thinking and process optimization, with strong desire to learn and grow. Brings keen understanding of project management principles and data analysis techniques. Ready to use and develop project management and data analysis skills.
Overview
10
years of professional experience
1
Certification
Work History
CORL Technologies
Project Management
06.2024 - Current
Job overview
- Led project management initiatives focused on the development and documentation of Standard Operating Procedures (SOPs) to ensure compliance with healthcare cybersecurity standards
- Led offshore teams to deliver critical product features, ensuring alignment with stakeholder requirements and project timelines.
- Acted as the voice of the customer, gathering and translating client feedback into actionable user stories and feature requirements.
- Managed and prioritized the product backlog, ensuring the highest-value features were delivered in each sprint cycle.
- Collaborated with CORL leadership, Product, and Development teams to define and refine the product roadmap based on business goals.
- Conducted User Acceptance Testing (UAT) to ensure product features met client expectations before deployment.
- Facilitated daily stand-ups, sprint planning, and retrospectives to maintain team productivity and address any roadblocks.
-Worked closely with stakeholders to prioritize deliverables, balancing competing priorities across multiple projects. - Coordinated with audit and compliance teams to integrate SOC 2 Type II, HITRUST, and ISO 27001 requirements into the product design.
- Delivered detailed progress reports and dashboards to senior leadership, providing transparency on sprint performance and project health.
Suhira Industries
Project Coordinator
01.2020 - 01.2024
Job overview
- Led API Export Initiatives: Managed the end-to-end export process of Active Pharmaceutical Ingredients (APIs) to international markets, ensuring compliance with regulatory requirements and maintaining high-quality standards throughout the supply chain
- Cross-Functional Collaboration: Coordinated with engineering, quality assurance, and regulatory teams to develop and implement standard operating procedures (SOPs) for API production and machinery recycling, ensuring seamless operations and compliance
- Market Analysis and Strategy Development: Conducted market research to identify potential clients and opportunities in the API export sector, leading to a30% increase in sales and establishing Suhira Industries as a competitive player in the market
Glaxo Smith Kline Pharmaceutical
Management Trainee- Vaccine safety
06.2018 - 07.2019
Job overview
- Assisted in the preparation of Individual Case Safety Reports (ICSR) and aggregate safety reports for regulatory submission, ensuring all necessary documentation met global pharmacovigilance standards
- Analyzed safety data from clinical trials and post-marketing surveillance to identify trends and potential safety signals, contributing risk assessments and safety profile evaluations
- Gained hands-on experience with MedDRA and WHO Drug dictionaries, facilitating accurate coding and reporting of safety data
Glaxo Smith Kline Pharmaceutical
Summer Intern- Market Access
04.2017 - 06.2017
Job overview
- Engaged with healthcare professionals and stakeholders to understand barriers to access, collecting feedback to enhance market access strategies
- Analyzed pricing and reimbursement policies across different hospitals and regions, contributing to the development of tailored pricing strategies
Alkem Laboratories Ltd
Regulatory Affairs Quality Assurance Intern
04.2015 - 06.2015
Job overview
- Assisted in Root Cause Analysis investigations, offering a quality perspective to understand and address deviations effectively
- Assisted in quality system audits and played a role in initiating Corrective and Preventive Actions (CAPAs)
Education
NMIMS University-School of Business Management
Master of Business Administration
07.2018
NMIMS University- School of Pharmacy and Technology Management
Bachelor of Pharmacy from Drug Regulatory Affairs & Pharmacovigilance
07.2016
Skills
- Tools & Software: MS Power App, SharePoint, MS Project, Microsoft Office Suite, MS Visio, SUGAM, Veeva commercial
- Core competencies: Familiar with essential pharmacovigilance documents such as: Standard Operating Procedures (SOPs), Individual Case Safety Reports (ICSRs), Periodic Safety Update Reports (PSURs), Risk Management Plans (RMPs), Safety Data Exchange Agreements (SDEAs), Signal Detection and Risk Assessment Reports
Certification
- Certified ScrumMaster (CSM)
- SAFe® 6.0 Product Owner/Product Manager (POPM)
Accomplishments
- Achieved rollout of new safety data management features, achieving 90% user adoption and servicing over 3,000 active users.
- Resolved product issue through consumer testing.
- Supervised team of 5 global members.
Availability
See my work availability
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Available
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tuesday
wednesday
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friday
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sunday
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Timeline
Project Management
CORL Technologies
06.2024 - Current
Project Coordinator
Suhira Industries
01.2020 - 01.2024
Management Trainee- Vaccine safety
Glaxo Smith Kline Pharmaceutical
06.2018 - 07.2019
Summer Intern- Market Access
Glaxo Smith Kline Pharmaceutical
04.2017 - 06.2017
Regulatory Affairs Quality Assurance Intern
Alkem Laboratories Ltd
04.2015 - 06.2015
NMIMS University- School of Pharmacy and Technology Management
Bachelor of Pharmacy from Drug Regulatory Affairs & Pharmacovigilance
NMIMS University-School of Business Management
Master of Business Administration
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