7 days old

Specialist, PV Global Safety Systems - Remote

Gaithersburg, MD 20877 Work Remotely
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We go where others wont, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world.Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect and enhance life.

JOB SUMMARY
The PV Specialist GSS will be integral in the day-to-day operations of the Global Pharmacovigilance department with a primary focus on Emergents Global Safety Database (Argus Drug Safety System) and associated Safety applications, Analytics. The role will need to demonstrate knowledge of safety / pharmacovigilance system requirements to meet business needs against the prioritized product portfolio, take ownership and be ultimately responsible for the daily operation and maintenance (including system updates, patches, etc.) of Emergents Global Safety Database. The role will manage applicable tools and methodologies to ensure existing processes and systems fully address the needs of the stakeholders including database hosting partner 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
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

Responsible for maintenance of Emergents Global Safety Database, and associated Signal detection applications, Analytics.
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 systems 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 systems host and internal functions.
Effectively communicate and coordinate with the PV team, internal functions, and external partners across multiple locations; providing updates as needed
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.

The above statements are intended to describe the nature of the work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects managements assignment of essential functions.

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

Knowledge:
Deep knowledge of Oracle Argus Drug Safety System
Good level knowledge Empirica, Analytics, will be a plus
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:

Can perform Oracle Argus Drug Safety System business configuration and validation
Aggregate report configuration in the Safety database
Can provide requirements input for implementation/upgrade of the Safety database

Abilities:
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

Per CDC guidelines, Emergent strongly recommends that all employees working on site are vaccinated to help ensure their safety, as well as the safety of fellow employees. This includes the use of good judgment when determining when the CDC guidelines advise that you stay home when ill.

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 values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable 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.

ABOUT EMERGENT

Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.

Our drive towards this vision informs all of our actionswhether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the communitywe strive every day to achieve this shared goal.

WE BELIEVE IN OUR VALUES

  • Lead with Integrity
    • We gain trust and confidence through ethics, quality, and compliance excellence
  • Stand shoulder to shoulder no matter what
    • We combine our best thinking and communicate openly to support each other.
  • Own it always
    • Every person at Emergent is engaged and accountable for delivering on our commitments.
  • Break through thinking
    • We take smart risks, pursue innovation and challenge ourselves to constantly improve.
  • Compete where it counts
    • We set the right goals and respect each other as we conquer them together.

Industry

  • Biotechnology
Posted: 2023-01-25 Expires: 2023-02-25

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Specialist, PV Global Safety Systems - Remote

Emergent BioSolutions Inc.
Gaithersburg, MD 20877
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