Overview Executive Director, Pharmacovigilance role at MindMed . MindMed is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Our mission is to be the global leader in the development and delivery of treatments that unlock new opportunities to improve patient outcomes. We are developing a pipeline of innovative product candidates, targeting neurotransmitter pathways that play key roles in brain health. MindMed 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 collaborate with Clinical, Regulatory, and other development functions to support the development and approval of novel medicines, ensuring operational efficiency and regulatory safety compliance. 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. The position will also manage PV contractors and build 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 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! Seniority level Executive Employment type Full-time Job function Research, Analyst, and Information Technology Referrals increase your chances of interviewing at MindMed by 2x Get notified about new Director Clinical Research jobs in Durham, NC. #J-18808-Ljbffr MindMed
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