Job Description

OVERVIEW OF POSITION:

The Vice President, Drug Safety and Pharmacovigilance position is responsible for determining the strategy for managing all operational processes and information systems supporting the global Drug Safety and Pharmacovigilance (PV) function within Equillium and coordinating such with its partners. Reporting to the Chief Medical Officer (CMO), this role will provide leadership to the PV & Drug Safety Team and woThis position will have a high degree of visibility and impact across the organization and oversees the management of the Equillium drug safety operations team and the Contract Research Organization who handle safety data from receipt to submissions, system operations, and quality management system. The VP also manages all DSPV operational compliance functions. The VP must possess a strong knowledge of global pharmacovigilance regulations, operational efficiencies, information systems, and best industry practices to effectively solve challenges and facilitate PV compliance.

ESSENTIAL DUTIES & RESPONSIBILITIES

DRUG SAFETY OPERATIONS

• Determine data management strategy for the global safety database including the allocation of case processing tasks between Drug Safety operations and Contract Research Organization (CRO) staff
• Manage and direct Drug Safety operations staff to oversee case management functions ensuring process optimization, case quality, and accurate regulatory reporting.
• Work with external partner(s)to jointly manage cases, safety reporting and signal detection across global development for molecule candidates
• Optimize utilization of information systems supporting case management (e.g., Oracle Argus).
• Manage implementation and/or operation of data analytics and data reporting tools to support drug safety compliance and analysis.
• Determine processes and/or tools supporting Pharmacovigilance signal management in accordance with GVP

DRUG SAFETY SCIENCES

• Provide medical oversight of the PV and risk management functions at Equillium
• Direct signal detection activities based on regular and ad hoc reviews of aggregate safety data
• Coordinate safety governance within the company and ensure cross-functional involvement in the evaluation of potential emerging safety issues and any associated risk mitigation/management measures that are proposed
• Participate as a key stakeholder in safety analyses and ensure proactive and timely benefit-risk assessments of safety data involving Equillium products

QUALITY MANAGEMENT

• Ensure compliance of the PV system for all safety data sources in collaboration with Equillium cross functional stakeholders
• Identify procedures for monitoring compliance with drug safety-related policies, procedures, applicable regulations, and agreements with contractual partners
• Establish and measure key compliance, quality and performance indicators (KCI/KQI/KPIs) for the drug safety department
• Plan, conduct and document internal and external GVP audits to assess compliance with applicable regulations, regulatory commitments, company SOPs, protocols and contractual obligations as applicable
• Provide recommendations for corrective and preventive actions and tracking corrective action commitments until closure
• Manage the operational compliance for partnership, participate in and support audits of contractual partners as necessary
• Act as the representative in various Company-wide committees
• Oversight of Department Process and Project Management Efforts.
• Proactively identify procedural gaps and challenges and propose/implement solutions, lead the establishment of business process optimization efforts to ensure efficiency and process improvements with the department.
• Formulate controls to maintain a system of third-party vendors to ensure compliance with PV reporting requirements.
• Ensures meeting business objectives while adhering to agreed scope, time, quality and budget and oversee preparation of inspection readiness and manage/participate in the audits of business partners
• Develop operating plans and budgets and allocate resources to ensure budgets, schedules and performance requirements are met
• Model the Equillium Values including promoting collaboration at all levels of the organization

SUPERVISORY RESPONSIBILITIES

• Will supervise employee(s) directly and indirectly through matrix, direct reporting or in collaboration with external partners

EDUCATION:

• MD, or PharmD in related discipline and 10+ years of related experience, or equivalent

EXPERIENCE:

• Equivalent combination of education and experience

SKILLS AND ATTRIBUTES:

• Demonstrated excellent organizational and planning capabilities – Excellent critical data analysis skills (clinical/systems/processes/compliance)
• Entrepreneurial, small/high-growth company experience is preferred
• Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors
• Demonstrated excellent teamwork, collaboration and interpersonal skills – Demonstrated leadership skills including significant managerial experience, team motivation, collaborative interaction, ability to problem-solve, prioritize, take initiative, meet challenges
• Excellent communication skills (oral/written)
• In-depth knowledge of US and international pharmacovigilance regulations (e.g. EU PV Legislation), FDA requirements, international guidelines (ICH/CIOMS) with experience in their practical application
• In-depth understanding of pharmacovigilance processes, regulatory compliance and standardization
• Pharmacovigilance data systems (Oracle Argus, signal detection, and data analytics tools) experience is required
• Experience managing the DSPV process in development and post marketing, and with partnered products

PHYSICAL DEMANDS / TRAVEL:

• The physical demands of this job are consistent with light office duties.
• Travel Requirement- Domestic and/or international

WORK ENVIRONMENT:

• The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.
• To perform this job successfully, an individual must be able to perform each role and responsibility satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required.
• This position’s primary work environment is in an office / traveling in the field as indicated.

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