Analytics and Reporting - Compliance Coordinator

Audit And Risk Operations Coordinator, Commercialization Analytics

This role supports the Market Research (MR) Compliance Team under direction and guidance from the MR Compliance Lead, working cross-functionally supporting BI&A activities related to Market Research and GVP Activities to ensure that internal audits responses, the third party risk process, and reporting are performed accurately and with sufficient detail. The role requires attention to detail and strong time management skills to ensure accurate and timely submissions. Specifically, this role will be responsible for:

• Development of an understanding of the regulations, methodology and processes that drive Market Research to ensure Client compliance with program requirements.
• Prepare and support audit activities for MR Pharmacovigilance Vendor and Affiliate audits and Inspections. Activities include working closely with PV Audit teams and vendor partners to ensure timely closure of Audit activities and continuous monitoring of trends.
• Manage internal vendor onboarding, including Third Party Risk Management (TPRM) process and system, which includes engaging vendor agencies in responding to requests and remediation of identified issues and escalating issues to the Compliance Lead
• Own document tracking and data governance for requests; maintain schedule of deadlines
• Provide reporting and analytical support to ensure Client compliance with government program regulations by tracking and monitoring on-going activities.
• Partner with internal stakeholders in order to provide status updates and manage expectations.
• Implement continuous improvement procedures to maintain operational effectiveness; making recommendations to strengthen and streamline the process and controls in place.

Qualifications and Expected Behaviors:

• BA/BS in relevant field of study or equivalent required
• Experience in an audit or compliance support role
• Ability to enforce process and compliance standards
• Strong communication skills in order to engage with teams on complex topics
• Intermediate knowledge of MS Excel, specifically formulas, pivot tables and charts
• Demonstrated ability to problem-solve in complex situations, gather potential solutions from a variety of sources, and synthesize to develop recommendations
• Demonstrated ability to balance multiple projects simultaneously and work independently to deliver timely results
• Experience with pharmaceutical industry and/or pharmacovigilance is a plus
• Strong background in QMS, Compliance or Quality Assurance preferred
• Experience in working across cultures preferred