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Compliance Manager, Auditing & Monitoring

Azurity Pharmaceuticals - India
Posted a month ago

LOCATION

Hyderabad · Onsite

EXPERIENCE

10+ Years

SKILLS REQUIRED

Risk Assessment & MitigationCompliance MonitoringCompliance auditingIssue RemediationFDA Compliance

Job description

Overview

Compliance Manager for Auditing & Monitoring with primary responsibility for Back-End Monitoring (BEM) and related oversight.

What you'll do

  • Lead and oversee strategy, development, and execution of ongoing Back-End Monitoring (BEM) activities.
  • Collect, review, track, and follow up on corrective actions, including oversight tools and compliance trackers.
  • Perform root cause analysis of compliance issues and track remediation, including trend analysis of emerging risks.
  • Support internal investigations and coordinate compliance audits and risk management activities.
  • Manage the Risk Assessment and Mitigation Process (RAMP), including documentation, trend analyses, and executive reports.
  • Maintain compliance incident management and reporting, ensuring timely documentation, escalation, and resolution.
  • Oversee and review contractor and temporary associate work as needed.

What you'll need

  • Bachelor’s degree in health science or related field.
  • 10+ years of compliance experience in the life sciences industry with a Bachelor's Degree.
  • Full knowledge of healthcare laws and regulations under the FDA, fraud and abuse laws, and privacy laws, and industry codes.
  • Excellent analytical and problem-solving skills to organize and interpret complex data and identify trends.
  • Understanding of simple statistical sampling methods for risk-based sampling.
  • Demonstrated expertise in compliance monitoring, auditing, and issue remediation.
  • Proficiency with Microsoft Office Suite, including intermediate to advanced Word and Outlook and advanced Excel and Power BI skills.

Details

  • Location: Hyderabad, India.

Read the full description and apply on the company’s own careers page.

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Compliance Manager, Auditing & Monitoring