Director, Global Medical Services Operations (East Coast Based Positio…
Axsome Therapeutics IncSalary not specified
- Full Time
- Senior (5 to 8 years)
Not SpecifiedCompensation
Junior (1 to 2 years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, Biotechnology, HealthcareIndustries
Requirements
Candidates should possess a Bachelor’s degree or equivalent formal academic/vocational qualification and at least 5+ years of relevant experience. They should have a thorough understanding of pathophysiology and the disease process, along with solid knowledge of relevant therapeutic areas. Strong critical thinking and problem-solving skills, including the ability to evaluate and escalate issues appropriately, are required. Proficiency in Microsoft Office products, particularly Outlook, Word, and Excel, is essential, as is computer literacy. A thorough understanding of global regulatory requirements and compliance with regulations and procedures is also necessary.
Responsibilities
The Sr Safety Spec will perform and potentially oversee day-to-day Pharmacovigilance (PV) activities within a highly regulated environment, driven by strict timelines. Responsibilities include collection, monitoring, assessment, evaluation, research, and tracking of safety information, collaborating with various parties such as project teams, client contacts, investigators, and adverse event/reporters. The role involves working independently to perform PV activities, potentially participating in on-call duties, operating in a lead capacity, providing assistance in developing procedural documents, preparing for and attending audits, mentoring staff, reviewing regulatory publications, maintaining medical understanding of therapeutic areas, reviewing cases for quality and accuracy, and participating in routine project implementation and coordination, including presentations and metric reviews.
Skills
Pharmacovigilance
Safety Monitoring
Regulatory Compliance
Medical Knowledge
Audit Preparation
Mentoring
Research and Evaluation
Thermo Fisher Scientific
Provides life sciences products and services
About Thermo Fisher Scientific
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.
Waltham, MassachusettsHeadquarters
1956Year Founded
$17MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
10,001+Employees