Corporate Compliance Lead

Pharvaris•Lexington, MA

1d•$95,000 - $110,000•Hybrid

About The Position

Pharvaris is a Nasdaq-listed late-stage biotech company developing bradykinin B2 receptor antagonists for bradykinin-mediated diseases. We are expanding the Legal and Compliance team and looking for a Corporate Compliance Lead to join our team and report to the Head of Corporate Compliance. This role will assist the Head of Corporate Compliance with the development, implementation, and maintenance of an effective corporate compliance program, aligned with the U.S. Federal Sentencing Guidelines, HHS-OIG General Compliance Program Guidance, and the DOJ's Evaluation of Corporate Compliance Programs. This role serves as a trusted business partner to the company's business functions, with a primary focus on the U.S. Medical Affairs and U.S. Commercial teams, including team members in customer-facing roles.

Requirements

Bachelor's degree required.
5+ years of progressive experience in pharmaceutical, biotech, or healthcare compliance.
Experience with U.S. healthcare laws and regulations, including FDA and HHS-OIG requirements.
Practical experience applying the federal Anti-Kickback Statute, the False Claims Act, and the Physician Payments Sunshine Act / Open Payments to commercial and medical activities.
Strong organizational and communications skills (oral and written) with a demonstrated attention to detail.
Ability to work independently and as part of cross-functional and matrixed teams.
Flexibility and ability to adapt to a fast-paced, challenging, hands-on matrixed environment.
Innate curiosity and desire to learn.

Nice To Haves

Certified in Healthcare Compliance (“CHC”) or Certified Compliance & Ethics Professional (“CCEP”) preferred.
Experience with rare diseases is desired but not required.
International (EU) experience is desired but not required.

Responsibilities

Assist with the day-to-day operations of the corporate compliance function, including executing the annual compliance work plan and functional objectives.
Support the Head of Corporate Compliance to advise the business on federal Anti-Kickback Statute (AKS) and the False Claims Act (FCA) requirements they apply to HCP engagements, speaker programs, advisory boards, business meals, sponsorships, grants, and patient support programs.
Own operational compliance with the Physician Payments Sunshine Act / Open Payments — including transfer-of-value data capture, aggregate spend, state spend transparency reports, and annual submissions to CMS and various states.
Assist with developing and executing an annual compliance monitoring and auditing plan, including field sales monitoring, T&E and expense monitoring, and thematic reviews (e.g., grants, sponsorships, HCP contracting).
Document and track compliance activities via reports, metrics, and dashboards, and provide regular updates to the Head of Corporate Compliance.
Assist with developing and delivering compliance training and education to U.S. Pharvaris staff on essential compliance topics.
Assist the Head of Corporate Compliance with triaging and investigating concerns and potential misconduct allegations involving healthcare laws, regulations, and internal policies, including matters raised through the Business Conduct Hotline.
Perform other duties as assigned by the Head of Corporate Compliance.