Senior Director of Pharmacovigilance - MAPS PBC

Remote (United States)

MAPS PBC is pioneering a new form of mental health care, beginning with the development of MDMA-assisted therapy as an FDA-approved treatment for PTSD. MDMA-assisted therapy is a new paradigm in the treatment of mental health, combining a medicine with psychotherapy to address the root causes of PTSD. It has been designated a Breakthrough Therapyby the FDA and the results of our pivotal Phase 3 clinical trial were published in Nature Medicine and profiled on the front page of The New York Times.  

 

MAPS PBC is a Public Benefit Corporation, with a dual mandate to generate shareholder value and public benefit. We are a wholly owned subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS), a non-profit working for over three decades to develop medical, legal, and cultural contexts for people to benefit from psychedelics. We are committed to continuing to lead the field of psychedelic medicine with integrity and ethics at the core.  

 

Why work for MAPS Public Benefit Corporation (MAPS PBC)? 

 

· We are a diverse team that shares a deep belief in the critical need for innovation and expanded access in the treatment of mental health conditions.

· We are entrepreneurial, collaborative, and open-minded in how we approach our innovative work. 

·  We are a new kind of pharmaceutical company that prioritizes public benefit over profit and is committed to sustainability, accountability, and transparency. 

 

We believe in diversity and inclusion of people of all backgrounds, genders, races, ethnicities, sexual orientations, educational backgrounds, military and veteran status, religions, abilities, and perspectives. MAPS PBC values and seeks applicants who are people of color, queer, transgender, gender non-conforming, and gender fluid people. MAPS PBC strives to establish a supportive, equitable and accessible work environment. 


Senior Director of Pharmacovigilance Executive Summary


The Senior Director of Pharmacovigilance will lead the development of MAPS PBC’s drug safety program and they will report directly to our Chief Scientific Officer. The Sr. Director of PV will bring significant experience in navigating FDA pre-approval inspections for new drug launches and will have strong working knowledge of PV regulatory requirements. The Sr. Director will optimize procedures and practices for programs to monitor and report on PV quality and compliance. This role will implement processes for the management of all PV controlled procedures, PV trainings, CAPAs, and inspection-related activities.

 

The successful candidate will work closely with cross-functional teams (ie. Clinical Development, Regulatory Affairs, Medical Affairs, Quality and Commercial) to assure that PV activities are conducted in compliance with regulatory requirements, PV Quality Management Systems, and established internal procedures with a patient safety perspective first



Key Responsibilities


  • Lead the PV department and vendors in preparation for product launch in the U.S.
  • Lead PV planning, implementation, and management of drug safety activities to support clinical development of company products and actively contribute to corporate risk management related to drug safety.
  • Contribute to implementation and management of REMS and Risk Management Plans, ensuring that product benefits outweigh possible risks.
  • Direct the development, preparation and review of; periodic and annual safety reports (e.g., DSUR, PADER), investigator communications, product labeling/package inserts and other reports as necessary that relate to product drug safety.
  • Provide expert drug safety input into all critical documents for clinical development plans of products (e.g., clinical study, protocols and amendments, ICFs, IBs, IMPDs, INDs, CTAs)
  • Manage PV budgets and contracts with outsourced vendors.
  • Monitor industry best practices and changes in global safety regulations and guidelines. Recommends changes and upgrades to existing departmental policies, SOPs and systems to ensure global regulatory compliance.
  • Mentoring team towards continuous improvement/enhancement of PV work procedures consistent with good pharmacovigilance practices for regulatory inspection readiness
  • Lead development of PV compliance programs and quality tools to enhance global PV quality and adherence to SOPs and regulations.
  • Design a global PV training program, including implementation, tracking, maintenance, and effectiveness checking of all PV training activities.



Minimum Requirements


  • Advanced degree required.
  • 13+ years of experience in the pharmaceutical industry (CNS or psychiatry experience a plus) with preferably a minimum of 5+ years in leadership positions in drug safety and pharmacovigilance in the clinical trial and post-marketing environments 
  • Strong working knowledge of global PV requirements (e.g., US Code of Federal (CFR) regulations; European Union (EU); European Economic Area (EEA); Guideline on Good Pharmacovigilance Practices (GVP) and ICH Guidelines.
  • Experience interacting with global regulatory authorities, including but not limited to FDA, EMA, MHRA, and BfArM.
  • Experience with managing and influencing cross-functional teams. Proven ability to develop internal relationships, as well as external relationships with clinical sites, Key Opinion Leaders, and outsourced vendors.
  • A dynamic leader who is highly resilient and achievement-oriented, with the ability to succeed in an environment that demands fast and well-founded decision-making on a vast number of multidisciplinary issues.
  • Skilled at working within an entrepreneurial environment that is mission-driven, results-focused, and research-oriented.
  • Excellent communication and time management skills, including working efficiently in a dynamic environment subject to quickly changing priorities and potentially conflicting deadlines.
  • Strong interpersonal skills and ability to work with all levels of the organization.



MAPS PBC is a distributed team that uses technology and periodic in-person gatherings to stay connected. We look for people who are comfortable with and skilled at remote work and collaboration.  


Competitive benefit package includes: 

Paid Time Off (PTO)

Sick Time

Holiday Pay

Employer paid medical, dental, vision, and life insurance (100% covered for employees + 50% for dependents)

Employer funded mental health HRA

Employer funded SEP IRA

FSA/Dep Care

Pet Insurance

Home Office Stipend

Conscious culture offering guided meditations, yoga and psychedelic ecosystem dialogues

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