Senior Adverse Events and Compliance Specialist
NCBiotech, Cary, NC, United States
Senior Adverse Events and Compliance Specialist
Location: Cary, North Carolina
Job Type: Permanent
Job Grade: 6
Function Innovation
Get to Know Your Area The AE & Compliance Specialist works with the AE & Compliance Manager to coordinate reporting, responsible for the timely and compliant reporting of Adverse Effects (AE) incidents and studies to ensure Envu’s adherence to global federal and state regulations, internal policies, and corporate procedures. Regular reporting to leadership ensures full understanding and timely deployment of findings. This role oversees regulatory compliance, drives risk and compliance priorities, and leverages technology and data analytics to enable real-time monitoring, reporting, and continuous improvement across the organization.
Adverse Effects Reporting & Compliance
Lead all aspects of AE reporting, ensuring compliance with global regulatory agencies and adherence to reporting timelines.
Collect, evaluate, and categorize AE information from internal and external sources, including Single Incident Reports, Aggregate Reports, and Study Reports.
Prepare and manage AE submission packages via ES software tools (D365) and other digital platforms.
Maintain accurate records in internal systems for proper archival, traceability, and audit readiness.
Serve as the primary point of contact for AE compliance queries and guidance across the organization.
Communicate reportable incidents and studies to internal stakeholders (Product Stewardship, Regulatory, Marketing, Sales) and external agencies as required.
Report AE to U.S. EPA authorities as needed by regulations.
Digital Reporting & Analytics
Develop, maintain, and optimize digital reporting systems for AE tracking, ensuring compliance with regulatory requirements.
Build dashboards, automated reports, and analytics to monitor submission timelines, AE trends, and compliance metrics.
Integrate data from multiple sources (D365, internal ES systems, external databases) into centralized, real-time reporting platforms.
Provide actionable insights to stakeholders, supporting decision-making, risk mitigation, and continuous improvement initiatives.
Train and mentor colleagues in the use of digital reporting tools and interpretation of analytics outputs.
Regulatory Oversight & Compliance Initiatives
Monitor and analyze compliance activities; collaborate with cross-functional teams to define and implement corrective actions.
Contribute to the interpretation of policies, regulations, and industry standards.
Lead internal compliance initiatives and high-complexity cross-functional projects.
Serve as company contact with regulatory agencies (e.g., U.S. EPA) and external vendors.
Proactively anticipate regulatory changes and recommend process improvements to maintain compliance.
Training & Mentoring: Develop and deliver training programs on AE reporting processes, systems, and regulatory requirements for global teams.
Provide mentoring and coaching to colleagues within area of expertise, fostering a culture of compliance and continuous learning.
Are You Ready for the Role? Main Requirements
Proven leadership skills managing high volumes of critical work.
Expert in identifying compliance risks and proposing proactive solutions.
Strong verbal and written communication skills across organizational levels.
Stay calm under high pressure.
Ability to build sustainable relationships with internal teams and regulators.
Expertise in leveraging data and technology (e.g., D365, Power BI, Tableau) to enhance performance and efficiency.
Excellent attention to detail, time management, and organizational skills.
Skilled in mentoring, training, and coaching colleagues.
Strong understanding of compliance risk vs. business risk.
Ability to lead multiple complex projects independently while meeting tight deadlines.
Envu is committed to creating an inclusive environment for all employees and applicants, regardless of ethnicity, color, race, religion, origin, age, gender, gender identity or expression, sexual orientation, or other conditions. And all opportunities are open to people with disabilities.
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Job Type: Permanent
Job Grade: 6
Function Innovation
Get to Know Your Area The AE & Compliance Specialist works with the AE & Compliance Manager to coordinate reporting, responsible for the timely and compliant reporting of Adverse Effects (AE) incidents and studies to ensure Envu’s adherence to global federal and state regulations, internal policies, and corporate procedures. Regular reporting to leadership ensures full understanding and timely deployment of findings. This role oversees regulatory compliance, drives risk and compliance priorities, and leverages technology and data analytics to enable real-time monitoring, reporting, and continuous improvement across the organization.
Adverse Effects Reporting & Compliance
Lead all aspects of AE reporting, ensuring compliance with global regulatory agencies and adherence to reporting timelines.
Collect, evaluate, and categorize AE information from internal and external sources, including Single Incident Reports, Aggregate Reports, and Study Reports.
Prepare and manage AE submission packages via ES software tools (D365) and other digital platforms.
Maintain accurate records in internal systems for proper archival, traceability, and audit readiness.
Serve as the primary point of contact for AE compliance queries and guidance across the organization.
Communicate reportable incidents and studies to internal stakeholders (Product Stewardship, Regulatory, Marketing, Sales) and external agencies as required.
Report AE to U.S. EPA authorities as needed by regulations.
Digital Reporting & Analytics
Develop, maintain, and optimize digital reporting systems for AE tracking, ensuring compliance with regulatory requirements.
Build dashboards, automated reports, and analytics to monitor submission timelines, AE trends, and compliance metrics.
Integrate data from multiple sources (D365, internal ES systems, external databases) into centralized, real-time reporting platforms.
Provide actionable insights to stakeholders, supporting decision-making, risk mitigation, and continuous improvement initiatives.
Train and mentor colleagues in the use of digital reporting tools and interpretation of analytics outputs.
Regulatory Oversight & Compliance Initiatives
Monitor and analyze compliance activities; collaborate with cross-functional teams to define and implement corrective actions.
Contribute to the interpretation of policies, regulations, and industry standards.
Lead internal compliance initiatives and high-complexity cross-functional projects.
Serve as company contact with regulatory agencies (e.g., U.S. EPA) and external vendors.
Proactively anticipate regulatory changes and recommend process improvements to maintain compliance.
Training & Mentoring: Develop and deliver training programs on AE reporting processes, systems, and regulatory requirements for global teams.
Provide mentoring and coaching to colleagues within area of expertise, fostering a culture of compliance and continuous learning.
Are You Ready for the Role? Main Requirements
Proven leadership skills managing high volumes of critical work.
Expert in identifying compliance risks and proposing proactive solutions.
Strong verbal and written communication skills across organizational levels.
Stay calm under high pressure.
Ability to build sustainable relationships with internal teams and regulators.
Expertise in leveraging data and technology (e.g., D365, Power BI, Tableau) to enhance performance and efficiency.
Excellent attention to detail, time management, and organizational skills.
Skilled in mentoring, training, and coaching colleagues.
Strong understanding of compliance risk vs. business risk.
Ability to lead multiple complex projects independently while meeting tight deadlines.
Envu is committed to creating an inclusive environment for all employees and applicants, regardless of ethnicity, color, race, religion, origin, age, gender, gender identity or expression, sexual orientation, or other conditions. And all opportunities are open to people with disabilities.
#J-18808-Ljbffr