Director, Global Medical Services Operations (East Coast Based Positio…
Axsome Therapeutics Inc- Full Time
- Senior (5 to 8 years)
Candidates should possess a Bachelor’s or Master’s degree in nursing, healthcare, or a related life-science field, along with a minimum of 5 years of experience in Safety, Clinical Research, or Pharmacovigilance. They should have at least 7 years of experience in global pharmacovigilance/drug safety, specifically within the EU and US, and demonstrate advanced expertise in global (EU/US) pharmacovigilance requirements and practices.
The Safety Operations Manager will oversee operational delivery and staff within Global Patient Safety (GPS) Operations, coordinating with safety vendors and GPS teams regarding case triage and processing, and supporting deliverables with the GPS GSL team. They will collaborate with internal and external teams on safety-related deliverables, communicate with clients and business partners regarding PV Agreements (PVA) / Safety Data Exchange Agreements (SDEA), proactively identify issues and areas for improvement, develop new processes and procedures, and ensure all activities comply with applicable client Controlled Procedures and regulations. Additionally, the role involves overseeing assignment of Safety Specialist tasks, engaging in the development of new processes, and performing other tasks as assigned by the line manager or Head of GPS.
Provides life sciences products and services
Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.