We're seeking an experienced Drug Safety Scientist to lead safety surveillance and risk management activities for both investigational and marketed products. This role is key to ensuring the integrity and accuracy of safety data, working closely with the Safety Physician/Medical Monitor and cross-functional teams to meet global pharmacovigilance requirements.
Key ResponsibilitiesLead and manage ongoing safety surveillance, signal validation, and aggregate reporting (PSUR, PADER, DSUR)
Conduct literature reviews and prepare materials for safety governance meetings
Handle ad hoc safety queries and regulatory authority requests
Support clinical development activities, including IB updates, DSMB presentations, CRF/ICF development, and safety narratives
Ensure compliance with evolving global pharmacovigilance regulations, SOPs, and internal quality standards
Minimum 3+ years of experience as a Pharmacovigilance Scientist
Minimum 5+ years in pharmaceutical, medical, or clinical research roles
Advanced degree preferred: PharmD, RN, MD, PhD, MPH, or NP
Strong analytical and writing skills with proficiency in Excel
Background in mental health or neurology therapeutic areas
Familiarity with MedDRA , Argus Safety , and safety database systems
Strong project management, communication, and leadership skills
Ability to work both independently and collaboratively within multidisciplinary teams
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