Director, Safety Operations

Overview

Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission.

AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene.

The Director of Safety Operations reports to the Global Head of Patient Safety. The Director will be responsible for creating, directing and managing the company's infrastructure and staff to support the operational aspects of the pharmacovigilance system, and adheres to all global regulatory requirements and internal processes and procedures. The qualified candidate will have experience in and perform multiple activities related to overall global safety operations strategy across the portfolio including AveXis case management, database strategy, vendor oversight, compliance, inspection readiness, budget, contracts and training.

Responsibilities

• Provide strategic planning, implementation, and management of Global Patient Safety (GPS) Pharmacovigilance Operations activities.
• Responsible for managing internal and external staff allocated to operational GPS activities, creating a highly efficient team across insourced and outsourced resources.
• Provides expert guidance and leadership both internally and externally based on in-depth knowledge of development and post-marketing safety requirements, per ICH; US and international regulations and guidelines; and Good Pharmacovigilance Practice (GPvP).
• Builds and implements pharmacovigilance systems fully compliant with the applicable worldwide Health Authority PV regulations.
• Ensures that the GPS Database supports the department needs, including specific workflows and reporting/querying functionalities.
• Provides oversight of systems and MedDRA updates in collaboration with the relevant vendor(s).
• Manage vendors and business partners. Provides vendor oversight and management for all outsourced or insourced PV activities, including establishing and monitoring key quality and compliance metrics.
• Develop and implement an inspection readiness program with the contribution of other GPS and non-PV stakeholders.
• Responsible for a compliant and quality execution of all operational activities related to case management and related activities. Oversees timely submissions of expedited reports to the FDA & other health authorities. Identifies immediately deviations and applicable corrective and preventive actions to maintain the compliance to reporting at its highest level.
• Establish a system for prevention and correction of deviations to compliance with internal and external stakeholders, in collaboration with the AveXis Quality group.
• Oversee the set-up of new safety projects, including development of study-specific Safety Management Plans and set up of safety systems and database configurations in the PV database to accommodate these trials and products.
• Contributes to, drafts and implements department SOPs and work instructions related to the GPS activities.
• Oversee to the signal detection, benefit-risk profile assessment, risk management and aggregate reporting activities with providing accurate reports from the GPS database.
• Effectively collaborates with key stakeholders at all levels in the organization. including Clinical Operations, Clinical Development, Regulatory Affairs, Legal, Medical Affairs and Manufacturing to develop compliant procedures in line with industry standards and best practices.
• Represents GPS as a leader on project teams, other departments, and committees as needed.

Qualifications

• Training in relevant subject, life science degree, and or Post-graduate specialization in project or business management.
• Min 5-10 years' experience in the pharmaceutical industry, predominately in drug safety/pharmacovigilance operations, having worked on both development and marketed products.
• Demonstrated leadership in building safety operations function and experience in vendor management.
• Experience of working in a cross functional team and strong project and business management skills.
• Experience in managing and supervising team is preferred.
• Credible knowledge of global regulations governing pharmacovigilance in the pharmaceutical industry and Research & Development processes.
• Strong organizational, planning, prioritizing and problem-solving skills.
• Effective multi-tasking skills, applied in different and complex assignments and ability to work effectively under pressure and under strict timelines.
• Ability to work both independently and collaboratively and use own initiative.
• Ability to communicate effectively both locally and globally, internally and externally.
• Operational expertise in ARGUS preferred.
• Proficient MS Office skills.
• Personality and attitude.
• Approachable, flexible and self-motivated.
• Open to changes, suggestions and innovations, continuously on the look-out for work processes' improvements.
• Tolerance for ambiguity and ability to adapt quickly to a changing business environment.
• Highly resilient, tenacious and resourceful.
• Occasional travel (up to 20%) for business and meetings.
• High attention to details.
• Strives to maintain a safe working environment through the prevention of accidents, the preservation of equipment, and the achievement of safe working practices.
• Maintains a positive and professional demeanor toward all customers and coworkers.
• Adheres to all policies and procedures of AveXis.
• Performs other duties as assigned.

The level of this position will be based on the final candidate's qualifications.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.

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