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Sr. Associate, Aggregate Report Compliance

1 month ago

Raritan, United States US Tech Solutions Full time

Duration: 12 months contract, Full-Time


Employment Type: W-2


Job Description:

Role can be 100% REMOTE

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

· In support of aggregate report compliance, the individual will be responsible for supervising compliance and ensuring appropriate documentation is completed when there are late submissions to Health Authorities. The Sr. Associate, Aggregate Report Compliance will generate compliance metrics and reports in support of MSQ Compliance and Risk Management key partners, including:

• Office of the Chief Medical Officer (OCMO) Senior Leadership Team

• Office of the QPPV

• Global Regulatory Affairs • International Pharmacovigilance Leadership

• Other partners across business Compliance metrics and data produced feed into:

• Quality Management Reviews

• Medical Safety Council Operational Compliance Committees

• Other compliance review venues and for other functional partners

· The individual will drive the precision and consistency of compliance metrics and be responsible for ensuring that publication of all standard compliance metrics are completed in a timely, accurate and consistent fashion and will innovate by streamlining processes and driving efficiencies.

· Keys for success in this role include the ability to develop partnerships with Global Regulatory Affairs, Local Operating Companies, and strategic vendor colleagues.

· Support the aggregate report tracking process and systems

· Monitor compliance of aggregate report submissions to Health Authorities and generation of compliance metrics



Responsibilities:

The individual, with oversight from the Manager of Aggregate Report Compliance and Vendor Oversight, will be accountable for prioritizing and ensuring that deliverables are completed on time and are accurate and consistent. The individual will 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 Requires problem-solving skills to interpret and analyze data and information

Experience in high volume work environment preferred.


Experience:

2


Skills:

· May travel for a possible mandatory meeting onsite for 1-2 days, not very often at all

· Pharmacovigilance experience needed

· Must be able to problem solve, and know when to ask for help

· Working within the Global Environment / Global Teams

· Regulatory Affairs experience

· MAIN ASPECT OF ROLE: Support Aggregate Tracking process

· Must be able to spot if data is incorrect on report



Education:

Bachelor’s Degree


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. To know more about US Tech Solutions, please visit www.ustechsolutions.com.


US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment 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

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