Executive Director, Pharmacovigilance

Summary

Join MindMed, a clinical-stage biopharmaceutical company, as the Executive Director, Pharmacovigilance (PV)! Lead drug safety for the company, collaborating with various departments to support the development and approval of novel medicines. Ensure operational efficiency and compliance with all regulatory safety obligations. Lead PV contributions to marketing applications and post-market safety surveillance programs. Manage PV contractors and build the PV function. This role reports to the Chief Regulatory and Quality Officer.

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

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

Benefits

• 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!