• Job Description

  Req#: JP-005334262

  Job Title: Manager Database Management & Analytics, CSPV

  
  

  Job Description

  Assist in the implementation of project-specific safety database configurations to meet the regulatory and business needs of the CSPV department. Participate in system validation activities for the safety database and other safety-related systems. Perform quality checks on configuration changes performed by the database service provider, identifying discrepancies between requests and implementations and resolving or initiating their resolution. Serve as a system administrator and perform configurations/master data updates such as code lists, user access, reporting rules, product, and study. Conduct pilot tests with E2b partners in the Development environment. Collaborate with CSPV and DBMA teams to complete configuration forms and coordinate with the Safety system service provider to finalize configurations. Maintain best practices for safety database configurations, customizations, aggregate reporting, data migration, data integration, E2B Gateway reporting setup, interface with EDC, and other new automation initiatives. Assist with data management of safety-related PV systems.

  Responsibilities

  • Implement project-specific safety database configurations to meet regulatory and business needs.
  • Participate in system validation activities for safety databases and related systems.
  • Perform quality checks on database configuration changes.
  • Serve as system administrator and update master data configurations.
  • Collaborate with teams to complete configuration forms and coordinate with service providers.
  • Maintain best practices for database configurations and reporting setups.
  • Assist with data management of safety-related PV systems.

  Essential Skills

  • Experience supporting Oracle Argus Safety is required.
  • Experience in safety reporting applications is required.
  • Knowledge of PV reports is helpful.
  • Relational database knowledge working with Oracle and SQL is required.
  • General knowledge of Electronic Data Interchange, particularly Axway B2Bi Interchange, is a plus.
  • Understanding global safety reporting requirements and ICH E2B guidelines is preferred.
  • Professional and proactive demeanor.
  • BS in Computer Science or equivalent qualification with at least four years of experience in Pharmacovigilance.

  Additional Skills & Qualifications

  • Knowledge of PV reports would be helpful.
  • General knowledge about global safety reporting requirements and ICH E2B guidelines preferred.

  Work Environment

  The role involves working with advanced database management systems and safety-related software applications. The position requires collaboration with various teams and service providers, ensuring configurations are aligned with best practices and regulatory requirements. The work environment is dynamic, focused on innovation and excellence in safety database management.

  Pay and Benefits

  The pay range for this position is $68.77 - $75.78/hr.

  Eligibility requirements apply to some benefits and may depend on your job
  classification and length of employment. Benefits are subject to change and may be
  subject to specific elections, plan, or program terms. If eligible, the benefits
  available for this temporary role may include the following:

  • Medical, dental & vision
  • Critical Illness, Accident, and Hospital
  • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
  • Life Insurance (Voluntary Life & AD&D for the employee and dependents)
  • Short and long-term disability
  • Health Spending Account (HSA)
  • Transportation benefits
  • Employee Assistance Program
  • Time Off/Leave (PTO, Vacation or Sick Leave)

  Workplace Type

  This is a hybrid position in Basking Ridge,NJ.

  Application Deadline

  This position is anticipated to close on Jun 23, 2025.

  About Actalent

  Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

  The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

  If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

• About the company

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