Mind Medicine is seeking an Executive Director, Pharmacovigilance (PV) to lead drug safety for the company.  Reporting to the Chief Regulatory and Quality Officer, this role will proactively collaborate with Clinical, Regulatory, and other development functions to support the development and approval of novel medicines, ensuring operational efficiency and compliance with all regulatory safety obligations. Importantly, the incumbent will lead PV contributions to marketing applications (NDA, BLA, MAA) for Mind Medicine’s portfolio and lead the development of post-market safety surveillance programs. Additionally, the position will be responsible for the management of PV contractors, as well as the building of a function (people, systems, and processes) to support development assets and marketed products.

Responsibilities

• Lead strategic and operational activities for the PV department.
• Responsible for all PV operations and compliance aspects of all Mind Medicine’s products throughout the product lifecycle from First-In-Human safety reporting to post-marketing surveillance for approved products
• Build PV infrastructure, PV systems and PV processes for inspection readiness and launch readiness in compliance with the global safety regulations and guidelines
• Serve as the drug safety expert for NDA, BLA, MA, leading PV contributions to relevant sections (2.7.4, ISS, labelling)
• Collaborate with the respective Medical Monitor to ensure alignment on PV process, including SAE and signal management processes
• Provide review, analysis and medical guidance during the case handling and reporting process for serious AEs (SAEs) received for the Mind Medicine investigational products
• Contribute to safety sections of clinical study documents including Study Protocols, Informed Consent Forms (ICF), Clinical Study Reports (CSR), IB Reference Safety Information (RSI), and other relevant documents
• Lead vendor selection and provide vendor oversight for all outsourced PV activities, including establishing and monitoring key quality and compliance metrics
• Responsible for PV Agreement/Safety Data Exchange Agreement with license partners and distributors
• Manage allocated operational resources to support the timely and compliant execution of all PV responsibilities

Requirements

• Terminal degree in a Health Care Profession is required (e.g., MD, DO, PhD, NP, Pharm D)
• 12+ years’ experience in drug development at global pharmaceutical or biotechnology companies, including 8+ years’ experience in PV operations in the clinical trial and post-marketing environments, is required
• Strong knowledge of global regulations governing pharmacovigilance in the pharmaceutical industry and Research & Development processes
• Experience in writing safety sections (2.7.4, ISS, narratives) of NDA, BLA, and successfully defending contents to Health Authorities
• Excellent verbal communication and presentation skills with ability to write clearly and concisely
• Strong interpersonal and communication skills for bridging between scientific and business participants, for negotiating timelines and for effective international collaboration

The starting base pay range for this position is $255,990.00 - $299,881.00. Compensation will be determined based on several factors including, but not limited to, skill set, years of experience, and the employee’s geographic location.

Employees in this role may be entitled to additional compensation, including bonus and equity. Benefits information is listed on our Jobs Page. The Company provides competitive benefits to employees including:

• 100% paid health benefits including Medical, Dental and Vision for you and your dependents
• 401(k) program with company match and immediate vesting
• Flexible time off
• Generous parental leave and some fun fringe perks!