Director, Global Medical Services Operations (East Coast Based Positio…
Axsome Therapeutics Inc- Full Time
- Senior (5 to 8 years)
Candidates should have proven experience in Pharmacovigilance or a related field, a general understanding of pathophysiology and the disease process, detailed knowledge of relevant therapeutic areas, strong critical thinking and problem-solving skills, good oral and written communication skills including paraphrasing skills, a good command of English and the ability to translate information into local language where required, computer literacy with the ability to work within multiple databases, previous exposure to Microsoft Office packages (including Outlook, Word, and Excel), an understanding of the importance of and compliance with procedural documents and regulations, the ability to manage and prioritize a variety of tasks and meet strict deadlines with limited supervision, strong attention to detail, the ability to maintain a positive and professional demeanor in challenging circumstances, and the ability to work effectively within a team to attain a shared goal.
The Drug Safety Specialist performs day-to-day PV activities, may participate in on-call duties for specific projects to ensure 24-hr coverage for intake of cases from investigative sites, reviews regulatory/pharmacovigilance publications and information sources to keep updated on current regulations, practices, procedures and proposals, maintains medical understanding of applicable therapeutic area and disease states, reviews cases entered for quality, consistency and accuracy, including review of peer reports, prepares and maintains regulatory safety reports, assists with routine project implementation and coordination (e.g., Clinical Trials, Endpoint Assessment Committee/Data Safety Monitoring Committee), including presentations at client/investigator meetings, and review of metrics and budget considerations, mentors less experienced staff.
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.