Roles and Responsibilities
Assist with aggregate reporting, clinical trial activities, signal management, literature review, and ad hoc regulatory responses for assigned product.
Support product safety surveillance activities.
Review study protocols, statistical analysis plans, and other clinical study-related documents.
Review tables, figures, and listings for safety data from clinical studies.
Review Investigator Brochure, Company Core Safety Information, and other Reference Safety Information.
Perform signal detection, evaluation, and management.
Support signal detection strategy.
Review adverse event data, literature, and other safety-relevant data for the purpose of signal detection.
Obtain a business understanding of clinical drug safety and pharmacovigilance.
Interact with cross-functional colleagues to develop greater understanding various aspects of drug development.
Experience, Education and Specialized Knowledge and Skills
Currently enrolled in a university pursuing a Pharmacy (PharmD) degree or graduate level degree (e.g., PhD, Master's) in a health science related field.
Embrace our core values: Put People First, Improve Lives, Cultivate Curiosity, Do Right, and Forge New Pathways.
Excitement about the vision and mission of Sage.
Equal Opportunity Employer. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.
EEO is the Law
EEO is the Law - Supplement
Pay Transparency Nondiscrimination
We value our relationships with professional recruitment firms. To protect the interests of all parties, and given the large volume of inquiries received from third-party placement agencies, we are not able to respond to all agency inquiries. We do not accept unsolicited resumes from any source other than directly from candidates for current or future positions. Submission of unsolicited resumes in advance of a signed agreement between our company and a placement agency does not create an implied obligation and, if an unsolicited candidate represented by a placement agency is hired, we are not obligated to pay a fee. Only approved recruitment firms will be allowed to provide services to Sage Therapeutics, Inc.#LI-Remote
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