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Sr. Associate, Aggregate Report Compliance

2+ years
$40.28/hr
10 May 27, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, CPC Certified, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Sr. Associate, Aggregate Report Compliance


Duration

  • 12 months contract, Full-Time

Employment Type

  • W-2

Location

  • 100% REMOTE

Job Description

The Sr. Associate, Aggregate Report Compliance, in conjunction with the Manager of Aggregate Report Compliance and Vendor Oversight, will support the oversight of the aggregate report tracking process and compliance monitoring of aggregate report submissions to Health Authorities.


Key Responsibilities

  • Oversight and Monitoring:

    • Support the aggregate report tracking process and systems.
    • Monitor compliance of aggregate report submissions to Health Authorities.
    • Ensure appropriate documentation is completed for late submissions to Health Authorities.
  • Compliance and Reporting:

    • Generate compliance metrics and reports.
    • Ensure precision and consistency of compliance metrics.
    • Publish standard compliance metrics in a timely, accurate, and consistent manner.
    • Innovate by streamlining processes and driving efficiencies.
  • Collaboration:

    • Develop partnerships with Global Regulatory Affairs, Local Operating Companies, and strategic vendor colleagues.
    • Provide support for Medical Safety Council Operational Compliance Committees and other compliance review venues.
  • Documentation and Processes:

    • Follow documented processes and procedures for aggregate report compliance monitoring and metrics generation.

Required Knowledge, Skills, and Abilities

  • Knowledge of GxP requirements and experience with safety processing, clinical safety study reporting, PV, and medical information preferred.
  • Ability to function in a global matrix environment.
  • Excellent communication and writing skills.
  • Understanding of and experience with multi-cultural working is preferred.
  • Project Management experience with organizing actions and managing team activities is preferred.
  • Proficiency in Microsoft Excel and SharePoint is required.
  • Strong problem-solving skills to interpret and analyze data and information.
  • Experience in a high volume work environment preferred.

Experience

  • Minimum of 2 years in a relevant role.
  • Pharmacovigilance experience needed.
  • Experience working within Global Environment / Global Teams.
  • Regulatory Affairs experience.
  • Ability to spot incorrect data on reports.

Education

  • Bachelor’s Degree required.

Travel

  • May require travel for a possible mandatory meeting onsite for 1-2 days, infrequently.

About US Tech Solutions

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. For more information, please visit US Tech Solutions.


Equal Opportunity Employer

US Tech Solutions is committed to providing equal employment opportunities to all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.


Recruiter Details

  • Name: Azhar
  • Email: Azhar@ustechsolutionsinc.com
  • Internal ID: 24-11941