Description

You will lead safety analysis and pharmacovigilance activities for clinical programs, ensuring prompt signal detection and compliance with global regulations. Your work supports the development of precision neuromedicines for patients with epilepsy, neuropathic pain, and bipolar disorder.

Requirements

• Experience leading aggregate reports and safety signal management
• Strong knowledge of global pharmacovigilance regulations
• Ability to collaborate cross-functionally with safety physicians and biostatistics
• Experience with clinical study protocols, IB, ICF, CSR review
• Proven leadership in drug safety within pharmaceutical or biotech industry

Responsibilities

• Lead aggregate report production (DSUR/PSUR/PADER) and literature surveillance
• Represent DSPV on clinical study teams for safety monitoring and SAE reconciliation
• Lead safety signal management and signal detection across assigned products
• Support RMP updates and REMS development and assessment reports
• Ensure PV compliance with global regulations and SOPs