The VP of Patient Safety & Pharmacovigilance will lead the overall strategic direction for Safety and Pharmacovigilance and oversee the operational delivery of safety and pharmacovigilance activities for Spark. Responsibility starts with products in the research phase preparing to enter clinical development and follows them through their lifecycle and commercialization, to ensure Spark appropriately identifies and manages the risks associated with our products and protects patients’ safety.

This role is accountable for ensuring that appropriate resources and pharmacovigilance systems and processes are in place for the evaluation and reporting of safety information, and other responses, to meet applicable global regulatory requirements for all products from development through post-marketing. This individual will provide expert guidance and decision-making and will help to shape the strategy and direction of the global function to meet the organizational needs and contribute toward the overall R&D strategy.

The VP of Patient Safety & Pharmacovigilance will work closely with the Development & Product Strategy leadership team, contribute the Patient Safety & Pharmacovigilance position to appropriate internal advisory committee and medical review committee discussions and decisions, and will partner with functions across and outside of Development & Product Strategy to support development of our products. This role will sit in Spark’s Philadelphia, PA headquarters.

Responsibilities

• Manage and lead the patient safety and pharmacovigilance function including oversight for activities, operations, and continued evolution toward a best-in-class organization.
• Leadership of patient safety for our products, including provision of a clearly defined safety strategy, oversight of product emerging safety profiles including signal detection/evaluation from all data sources and risk-benefit evaluation/risk management including appropriate capture of this in IBs, ICFs, protocols, and other clinical documents as required.
• Leadership of pharmacovigilance activities for our products, including safety database management, case processing and reporting, query resolution, and oversight for timely and quality preparation of required periodic reports and submission documents (e.g., DSURs, PBRERs, RMPs, etc.)
• Provide direction and leadership regarding vendor selection and management.  Accountable for effective oversight of outsourced operational activities.
• Oversight for and appropriate management of PV agreements, safety data exchange agreements, safety management plans, and other operating procedures with business partners as required.
• Maintain expert knowledge of current ICH and health authority requirements, expectations, and trends in patient safety and pharmacovigilance, and ensure compliance in all activities.  Ensure readiness for health authority inspections and partner audits, and represent Spark in inspections, audits, and other health authority meetings as required.
• Ensure appropriate process and training infrastructure in place, including through global Standard Operating Procedures (SOPs) and Work Instructions, and training plans for staff associated with safety and pharmacovigilance activities.
• Set vision and strategy for patient safety and pharmacovigilance organization in context of organizational vision and strategy, and lead organization to deliver on this.

• Line management and senior leadership accountabilities for patient safety and pharmacovigilance operations leads, including hiring and onboarding when needed, managing performance, developing people, fostering Spark’s culture/mission/vision/values, and cultivating inclusion.
• Represent patient safety and pharmacovigilance in senior leadership forums including contributing the safety and pharmacovigilance position in advisory or review committee discussions for our projects.

Education and Experience Requirements

• MD/DO degree required.
• 15+ years of experience in global drug safety/pharmacovigilance in pharma, biotech, medical device industry or equivalent, including 5+ years in a leadership role managing people and identifying organizational needs (talent, process, technology).
• Experience with regulatory agencies; hands-on experience contributing to safety components of BLA/NDA/MAA preparation and delivery through to product approval required.

Key Skills, Abilities, and Competencies

• Thorough understanding of ICH-GCP, cGMP, FDA, EMA, and other regulatory requirements pertaining to adverse event assessment and reporting, and post-marketing requirements for all markets where Spark products are distributed.
• Able to interpret and apply medical information, instructions, policies, procedures and guidelines pertaining to drug safety; able to create and implement processes and structures to standardize pharmacovigilance function.
• Demonstrated technical expertise including a thorough understanding of Individual Case Safety Reports (ICSR) processing operations and a working understanding of common drug safety databases
• Ability to distill and communicate complex clinical issues in a scientifically sound and understandable way
• Excellent leadership qualities including strategic thinking, analytical problem-solving skills, negotiation skills, people and resource management expertise.
• Ability to work easily across all levels; comfortable dealing directly with the CEO and others at the C suite level and working collaboratively with cross-cultural and global teams.

Setting Strategy

• Demonstrates a long-term perspective that extends beyond the immediate initiatives; visualizes and articulates a clear direction for Spark during times of uncertainty
• Intellectual curiosity and dedication to science, innovation, and complex problem-solving
• Commitment to strategic priorities and an increasingly aligned and disciplined organizational strategy
• Executing for Results
• Focuses on how things are done as much as what is done; drives a culture of high performance with increased attention to discipline and process
• Sets aspirational goals to take organizational performance to the next level, reinventing the operating model when appropriate; goes beyond conventional performance benchmarks to set world class best practice
• Navigates change and uncertainty; is agile in responding to feedback from within and outside the organization

Leading Teams

• Embraces and embodies the Spark values: “break the barriers, own your excellence, commit to collaborate, demonstrate the respect you seek, and above all, champion the patient;”
• Able to learn from colleagues, embraces perspectives from different backgrounds and fields, and step back to allow others to take action
• Thoughtfully leads through influence and maintains focus on larger priorities; delegates effectively while managing performance and holding direct reports accountable

Building Relationships and Using Influence

• Collaborates and looks to support other leaders; sees value in championing the work of the group over the individual
• Offers enthusiasm and empathy toward other leaders and their respective departmental goals; influences and ensures alignment toward common priorities
• Able to connect, engage in open dialogue, and disagree when necessary

This role requires a minimum of three days a week in our Philadelphia office.