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IT R&D Business Partner, Pharmacovigilance (PV) & Research (Remote)

Employer
Global Blood Therapeutics
Location
Working from Home
Start date
Jul 16, 2022
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Job Details

IT R&D BUSINESS PARTNER, PHARMACOVIGILANCE (PV) & RESEARCH (Remote)

Position Summary:

The IT Business Partner, PV & Research will collaborate with internal and external stakeholders to develop and implement technology solutions in support of IT and business strategy. This includes the ability to lead continuous business process improvement, view the end-to-end business, and fulfill and anticipate business and customer needs with innovative data solutions that help achieve the overall company objectives.

This position will support the Pharmacovigilance, Drug Safety, Research organizations across multiple disciplines such as Veeva Safety and SafetyDocs, Electronic Lab Notes, Computer Systems Validation,

Essential Duties and Responsibilities:

  • A hands-on technical role, the ITBP will also be a critical and strategic thought partner to their function’s leadership team to understand their strategic goals and where technology can and should enable those goals
  • Develop project definition in partnership with business sponsors for multiple, concurrent projects. This includes facilitating requirements gathering and process mapping
  • Continually assess business needs and implement measures that will ensure business expectations are met or exceeded by enhancing system capability and performance
  • Manages moderately sized projects with some multidisciplinary team members and moderate technical scope in line with IT roadmap and objectives
  • Manage and oversee vendors and consultants providing solutions
  • Leads the development and documentation of optimized business processes and change initiatives that meet business needs and support achievement of goals and objectives
  • Responsible for providing tier 2 application support for R&D applications
  • Assess, provide application solutions and recommendations to all levels of management
  • Author/Review validation testing protocols documents for GxP applications
  • Assist in the development of safety system administration SOPs
  • Support the resolution of issues pertaining to the safety system and interface with other PV tools
  • Support routine dictionary upgrades and ad-hoc report development
  • Manage and support the implementation and validation of transmission gateways and aggregate safety reports
  • Participate in system validation activities and collaborate with project team on Validation Plans, User/Functional Requirements, Risk Assessments, Validation Summary Reports, etc.
  • Ability to execute protocols, perform testing sequences and change controls
  • Test fixes and perform post-resolution follow-ups to ensure problems have been adequately resolved

Qualifications:

  • Bachelor’s degree with minimum 6+ years of experience in IT/business management, with relevant experience working in pharmaceutical/biotech industry
  • Experience required in Veeva Safety, and Argus, and in relevant work domains – Drug Safety, Pharmacovigilance, and Research Informatics
  • Project management experience with proven adaptability to shifting project schedules, priorities and assignments; able to make effective decisions
  • Ability to evaluate changing needs and provide accurate information based on the evaluation
  • Knowledge and experience working within an SDLC framework and computer system validation
  • Demonstrated experience working in a regulated environment including a thorough understanding of 21CFR Part 11
  • Ability to analyze and define business requirements and translate into technical solutions
  • Must have strong critical thinking and analytical skills
  • Must possess excellent communication (oral and written) and problem-solving skills
  • Effective project management skills are essential; change management capability and desire to innovate and help lead change

Fit with GBT culture:

  • Ability to build strong relationships with co-workers of various backgrounds and expertise
  • Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
  • Values-based leadership consistent with GBT's Core Values
  • Excitement about the vision and mission of GBT
  • Flexibility
  • Integrity

NOTE:  This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law.  This position may require you to work onsite or interact in person with customers of the Company and/or work onsite from time to time at the Company’s facilities.  The Company requires all employees working in its facilities (including attending in-person meetings and events) to be fully vaccinated from COVID-19 (except as required by applicable law).  Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for a disability/medical condition or sincerely-held religious belief, and/or as otherwise required by applicable law.  The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. This position requires you to maintain a fully-vaccinated status against COVID-19, subject to reasonable accommodations required by applicable law. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.

 

Company

Global Blood Therapeutics (GBT) is a biopharmaceutical company dedicated to the discovery, development and delivery of life-changing treatments that provide hope to underserved patient communities. Founded in 2011, GBT is delivering on its goal to transform the treatment and care of sickle cell disease (SCD), a lifelong, devastating inherited blood disorder. The company has introduced Oxbryta® (voxelotor), the first FDA-approved treatment that directly inhibits sickle hemoglobin polymerization, the root cause of SCD. GBT is also advancing its pipeline program in SCD with inclacumab, a p-selectin inhibitor in development to address pain crises associated with the disease. In addition, GBT’s drug discovery teams are working on new targets to develop the next generation of treatments for SCD. To learn more, please visit www.gbt.com and follow the company on Twitter @GBT_news.

Find Us
Website
Location
181 Oyster Point Blvd
South San Francisco
California
94080
United States
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