Contract – Program Leader, PVRM Veeva Configuration and Migration

CONTRACT – PROGRAM LEADER, PVRM VEEVA CONFIGURATION AND MIGRATION

Position Summary:

The Program Director will be responsible for the oversight and management of safety data-related activities regarding the development of the Veeva migration from PVL and the configuration of the new Veeva Safety Database for PVRM such as, but not limited to, oversight of project plan and deliverables, timelines, and adherence to project budget in collaboration with IT, quality and other GBT stakeholders. This includes the planning and execution into production of the pharmacovigilance database. This position reports to the VP of PVRM.

This position will work closely with the PVRM Vendors, Veeva, GBT IT and Quality departments.

Essential Duties and Responsibilities:

• Oversight of PV configurations of Veeva PV database and links to other essential regulatory systems within GBT
• Oversight of the migration plan and execution of data from the PVL safety system into the new GBT Veeva systems
• Oversee development of critical safety aggregate line listings needed to perform daily PV activities
• Participate in implementation & testing of system changes and oversight of preparation and execution of test scripts to ensure proper validation of the new Veeva PV database, systems, and reports
• Work closely with the PVRM to ensure consistent data entry processes across all products during the migration
• Work closely with IT and other GBT vendors and PVRM staff to troubleshoot, configure, and administer functions on our business applications
• Collaborate and coordinate with cross-functional team members to assist in the design, review, and creation of high-quality safety database output/listings
• In collaboration with Veeva personnel develop systems for organizing data to analyze, identify and report data and trends

Qualifications:

• Bachelor’s degree and a minimum of ten years of experience in supporting PV databases and systems in a pharmaceutical company, or equivalent
•  Must have a good understanding of global pharmacovigilance regulations specifically US FDA and the EU GVPs
• Must have experience working with standard safety software and Veeva
• Experience with reporting tools such as Tableau, Spotfire, Cognos, or Business Objects preferred
• Familiarity with signal detection and pharmacovigilance processes a plus
• Familiarity with PV dictionaries such as MedDRA and Who product dictionaries
• Prior experience with computerized systems validation preferred
• Must have strong analytical and critical thinking skills, with the associated curiosity to enable solving complex problems with little assistance
• Must be initiative-taking, detail oriented and able to multi-task
• Must possess excellent communication (oral and written) skill regarding both medical and technical topics
• Must have strong interpersonal/organizational skills
• Must maintain superior customer service at all times with all users
• Must possess the ability to work in a team environment and follow written policies/procedures
• Must be comfortable in a fast-paced, demanding work environment
• Flexibility to work outside of normal working hours or on-call arrangements to support the global drug safety organization
• Limited travel within the US may be required

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 requires you to work onsite 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.