Associate Director - Drug Safety & Pharmacovigilance Operations

March 18

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Sage Therapeutics

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Sage Therapeutics is a biopharmaceutical company dedicated to transforming the treatment of brain health disorders. The company focuses on developing novel medicines to impact conditions such as depression, neuropsychiatry, and neurology through its innovative research on GABA and NMDA receptors. With a commitment to patient advocacy and flexible work arrangements, Sage Therapeutics aims to lead in the development of next-generation medicines and improve global brain health.

CNS disorders • Neuroscience • Brain Health • Mental Health • brain disorders

201 - 500 employees

Founded 2010

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

📋 Description

• SAGE Therapeutics is searching for an experienced Associate Director, Drug Safety & Pharmacovigilance (DSPV) Operations. • Work on projects and processes ensuring strategies of the department are executed within global safety legislation and requirements. • Participate in the review and execution of DSPV Operations safety data collection strategy across clinical trial and commercial programs. • Provides oversight and review of vendor case processing activities. • Leads process improvement initiatives ensuring process consistency across DSPV procedures and project documents. • Actively contributes to ongoing inspection readiness activities for DSPV Operations.

🎯 Requirements

• Bachelor’s degree in nursing, pharmacy, or other health care related profession or life sciences required. • 6+ years of direct “hands-on” Drug Safety and Pharmacovigilance experience. • Master’s degree in health care related profession preferred, but not essential. • Vendor management experience. • Knowledge of FDA, ICH, and EU Regulations and Requirements for Pharmacovigilance. • Experience using ARISg, Argus, or other Safety Database applications required. • Strong analytical and problem-solving skills with excellent attention to detail. • Strong verbal, written, and technical communication and presentation skills. • Proficiency in standard desktop software programs (Word, Excel, Outlook). • Strong team player that is solution-oriented. • Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors. • Possesses strong written and verbal communication skills.