Corporate Compliance Lead

Corporate Compliance Lead

Legal and Compliance – Hybrid/Remote – US (East Coast preferred)

 

Pharvaris is a Nasdaq listed late-stage biotech company developing bradykinin B2 receptor antagonists for bradykinin-mediated diseases, with offices in Switzerland (Zug), the Netherlands (Leiden) and the USA (greater Boston area). We aim at bringing new, more convenient options to bradykinin-mediated angioedema patients who suffer sudden and prolonged attacks of swelling in multiple areas of the body including the airway, which can be life-threatening. We have a culture built on the core values of considering others carefully, leading with trust, ensuring rigor and diversity of thought, and contributing freely. Our company is driven by individuals committed to developing breakthrough therapies which can have a real impact on people’s lives. If you are looking for a place where your work can have meaning, and you can make a difference – Pharvaris is the place for you!

As we are expanding the Legal and Compliance team, we are looking for a Corporate Compliance Lead, to join our team and report to the Head of Corporate Compliance.

They 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.

Location

At Pharvaris we promote and enable a flexible hybrid work environment, where our employees choose from where (and, to some extent, when) they prefer to work. Whilst this is a remote/hybrid role, you must be located in US (East Coast preferred).

Main 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.

Requirements

Education & Certifications

• Bachelor's degree required.
• Certified in Healthcare Compliance (“CHC”) or Certified Compliance & Ethics Professional (“CCEP”) preferred.

 

Experience

• 5+ years of progressive experience in pharmaceutical, biotech, or healthcare compliance. Experience with rare diseases is desired but not required.
• Experience with U.S. healthcare laws and regulations, including FDA and HHS-OIG requirements. International (EU) experience is desired but not required.
• 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.

We are looking for someone that has

• 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.

 

What We Offer

At Pharvaris we promote and enable a flexible hybrid work environment, where employees have flexibility in choosing their work location and, to some extent, their working hours. This flexibility includes the option to work remotely or from our office (Lexington, MA).

Pharvaris is committed to fair and equitable compensation practices. The base salary range for this role is $95,000-$110,000 per year. Actual compensation will depend on various factors, including but not limited to depth of experience, skill set, overall performance, and education.  Pharvaris believes in providing a competitive compensation and benefits package. Base salary is just one component of our competitive total rewards strategy.  We also offer annual performance bonus eligibility, equity (RSUs) as a long-term incentive, a comprehensive range of market-competitive benefits, uncapped paid time off, and other incentive compensation plans (where applicable).