Specialist, Pharmacovigilance - Global Safety Systems (GSS)

Compensation

: $87,090.00 - $129,260.00 /year *

Employment Type

: Full-Time

Industry

: Energy/Power



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Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.

The PV Specialist - GSS will be integral in the day-to-day operations of the Global Pharmacovigilance department with a primary focus on Emergent's Global Safety Database (Argus Drug Safety System). The role will have ownership and be ultimately responsible for the daily operation and maintenance (including system updates, patches, etc.) of Emergent's Global Safety Database. The role will work closely with the database's host (Oracle) and other relevant third parties. In addition, the PV Specialist will provide all official reports from the system for internal review and Health Authority submissions. The role will also be responsible for any data migrations between Emergent and third parties.

Essential Functions
Responsible for maintenance of Emergent's Global Safety Database
Serve as system administrator
Ensures system safeguards are implemented and maintained
Responsible for troubleshooting and debugging application issues
Daily oversight and direction of any third-party service accounts, including issuing and management of service ticket requests
Accountable for specific application deliverables, such as configuration specification document updates, patches, updates, etc. in collaboration with system's host
Establishes and executes search parameters for reports from the safety database
Ensures submission portals are maintained, operational, and compliant
Leads any data migration and validation projects
Provide IT expertise during projects with the system's host and internal functions
Effectively communicate and coordinate with the PV team, internal functions, and external partners across multiple locations; providing updates as needed
Serves as SME for audits/inspections
Maintains well organized, auditable files
Provides reconciliation support to other Global PV functions, as needed
Participates in PV activities, including but not limited to, regulatory responses, aggregate reports, presentations, and signaling
Willing to support on weekends and/or after hours when during emergencies
EDUCATION, EXPERIENCE, SKILLS
Education
BS/MS degree in computer science or equivalent
Experience
Minimum of 2 - 5 years of IT experience
2+ years of experience in SaaS or software customer support (or similar function) preferably in a GxP environment
Deep knowledge of Oracle Argus Drug Safety System
Good level knowledge of SQL
Familiar with GxP and Computer System Validation concepts
Familiar with relational database concepts and web application concepts
Knowledge of Pharmacovigilance (Drug Safety), preferred
Skills
Excellent problem-solving and troubleshooting skills with the ability to provide innovative solutions to complex technical problems
Strong leadership skills, preferred
Excellent communication, facilitation, and presentation skills and experience in interacting with both business and IT individuals
Self-driven personality, keen learning attitude, and a good team-worker
Ability to quickly adapt to rapidly changing business demands

PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS

There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.

Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.

Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .

Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.
Associated topics: climate, emr, environment, hazard, healthy, hospital, inspector, nursing, wastewater, wastewater treatment plant * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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