Director, Medical Safety PV

Definium Therapeutics

23d

About The Position

Definium Therapeutics, formerly known as Mind Medicine, 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, with and without acute perceptual effects, targeting neurotransmitter pathways that play key roles in brain health.
Founded in 2019, we are continuously expanding our presence and global footprint. We are constantly searching for high-impact individuals in various clinical, technical and business operations domains to strengthen our team of patient-centric, intelligent individuals.
Definium Therapeutics is seeking a Director, Medical Safety Pharmacovigilance (PV) to lead risk management and safety surveillance in Pharmacovigilance. Reporting to the Executive Director of Pharmacovigilance, this role will proactively collaborate with Clinical, Regulatory, and other stakeholders to support clinical development and approval of novel medicines and develop processes and procedures that ensure adherence to global regulatory requirements for risk management and safety surveillance. The incumbent will provide input to key documents (e.g., periodic/aggregate reports, Investigators Brochure, protocols, clinical study reports, and marketing applications) for Definium’s portfolio.

Requirements

• Terminal degree in a Health Care Profession is required (MD, DO, PharmD); epidemiology background a plus
• 8 years in Pharmacovigilance with a minimum of 5 years proven experience in risk management, signal detection, and data analysis from sources generating adverse event information
• Knowledgeable of global Pharmacovigilance requirement and regulations regarding risk management plans, signal management, REMS, and aggregate/periodic reports
• Demonstrated ability to translate strategy into action, excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks
• Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations
• Independently motivated who can thrive in a fast growing/evolving, innovative environment while remaining flexible, proactive, resourceful, and efficient
• Knowledge and proficiency in utilizing data analysis tools, drug safety database, MedDRA, WHODrug, and document management systems
• Strong medical and scientific writing skills and ability to review literature databases for key information
• Ability to proactively and clearly communicate and identify risks/issues/concerns to senior Pharmacovigilance leadership in a timely manner with recommended solutions
• Strong interest in working collaboratively with senior Pharmacovigilance leadership to build the risk management division of the Pharmacovigilance department

Responsibilities

• Leads and manages signal management activities (clinical surveillance, signal identification, validation, analysis and prioritization) and closely collaborates with medical monitors and clinical scientists to provide clinical assessment and recommendations for continuous benefit-risk evaluation throughout the lifecycle of Definium medicinal products, and in compliance with regulatory requirements and company standard operating procedures
• Responsible for providing high-level safety expertise in clinical evaluation of all AEs including review of all safety case narratives, aggregate safety data, and relevant literature within or external to the safety database to assess the impact on the benefit-risk profile throughout the lifecycle of Definium products
• Leads and collaborates cross-functionally with medical and clinical scientists to develop, implement and maintain risk management activities which may include benefit-risk analysis in sections of clinical trial protocols, Investigators Brochure, informed consents, Clinical Study Reports, periodic reports (DSURs, PBRERs, PADERs), and/or any applicable risk management plans and REMS obligations
• Represents PV in collaborating with relevant company stakeholders in the development, review, and/or maintenance of Definium products Reference Safety Information, company core safety information, and other labeling, as required or directed
• Prepares and reviews key safety sections of the Investigators Brochure, protocols, informed consents, clinical study reports, and regulatory filings, as required
• Provides strategic input into regulatory responses and/or requests and clinical development programs
• Serves as a member of the safety governance committee providing safety analysis reports and/or presentations to characterize and communicate changes or key insights into Definium product(s)
• Responsible for keeping current with global Pharmacovigilance regulations and industry standards especially as it pertains to risk management and signal management practices
• Works collaboratively with internal and external Pharmacovigilance stakeholders and team members to ensure regulatory compliance and maintain Pharmacovigilance quality system
• Acts as the Subject Matter Expert in risk management and signal management procedures and processes during audits and inspections

Benefits

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

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree