Manager, Pharmacovigilance 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 Manager, Pharmacovigilance (PV) Operations is a technical expert in Global Patient Safety who establishes and maintains regional PV operations in collaboration with partner organization, local vendors and local marketing authorization holders (MAHs). In this role, the individual will provide technical expertise to the Global Patient Safety (GPS) Operations Team in managing the AveXis local and global Safety System (AGSS) functionality. The Manager will support the Argus Safety system, oversee the hosting vendor and ensure that requests for system issues, enhancements and other system changes are resolved in a timely manner.

This individual should be a self-starter with excellent pharmacovigilance knowledge and project management capabilities in pharmacovigilance who is seeking to be part of an innovative and fast-paced team to support the company's drug development activities.

Responsibilities

• Maintains and establishes the global/regional pharmacovigilance (PV) system in collaboration with partner organizations, local marketing authorization holders (MAHs) and Vendors.
• Primary contact for PV Operations in regions (US, EU, Latin America and Asia Pacific).
• Owner of the design of processes to meet local PV requirements.
• Primary liaison between Partner Country Offices and AveXis regional staff for PV.
• Establishes local PV processes with local MAH and vendors.
• Works with Manager, Global Safety Operations to incorporate local PV requirements in the global system.
• Liaise with Global Risk Management scientist to ensure local requirement are incorporated for the risk management plan.
• Provide back up and overflow support for Manager, global safety operations.
• Accountable for the day-to-day oversight of the hosting vendor and managing SLAs (service level agreements) to ensure that outstanding tickets are resolved in a timely manner.
• Manage and track the status of system change requests, enhancements and/or support efforts.
• Support planning and implementation of safety system enhancements and upgrades in collaboration with the vendor.
• Work with vendor, Clinical Operations Team and Safety Operations team to troubleshoot E2B reporting issues.
• Maintains list of reporting algorithms and labelling decisions.
• Contributes to testing of new system configurations and report design.
• Serves as resource for inspections and audits, including delivering database queries.

Qualifications

• Bachelor's degree in a Life Sciences discipline, Nursing or Pharmacy.
• 7-10 years' experience working within the Drug Safety/ Pharmacovigilance domain including pharmacovigilance operations in regions (EU, US, Latin America, Asia Pacific).
• At least 3 years of pharmacovigilance systems and operations experience.
• Experience with managing PV database hosting vendor and business partners.
• Strong knowledge of rules and regulations applicable to the Global Safety industry.
• Attention to detail, results-oriented and persistent with excellent organizational skills.
• Self-motivated and ability to work independently in a fast-paced environment, prioritize multiple tasks and recognize time sensitivity.
• Credible knowledge of global regulations governing Pharmacovigilance for products in clinical development and post-marketing.
• Strong project management, organizational, planning, prioritizing and problem-solving skills.
• Ability to work both independently and collaboratively and use own initiative.
• Ability to communicate effectively both locally and globally, internally and externally.
• Proficient MS Office skills.
• 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 10%) for conferences, meetings and professional development activities.
• 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.

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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