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Analyst 2 - Compliance

3 months ago

Raritan, United States Mindlance Full time

Sr. Associate, Aggregate Report Compliance

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

OTHER DUTIES
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.

Required Minimum Education:
Minimum of Bachelor's Degree in relevant discipline (Business, Science, Medical, Operations, etc.) with 4 years of pharmaceutical industry experience or advanced academic degree with 2 years of pharmaceutical industry experience.

Required Years of Related Experience: Minimum of 2 years of experience in pharmacovigilance case processing, aggregate reporting, and/or PV compliance monitoring.

EEO:

"Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of - Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans."