Director, Drug Safety & Pharmacovigilance Operations - Remote

Overview

The Director, Drug Safety & Pharmacovigilance Operations will be responsible for managing safety and PV related activities involving VALTOCO® (diazepam nasal spray) and Neurelis’ suite of investigational compounds. This role will manage external pharmacovigilance vendors regarding the collection, processing and reconciliation of drug safety information and ensure these operations are conducted in compliance with applicable regulations, guidelines and standards.

In Short

• Manage safety and pharmacovigilance activities for investigational compounds.
• Supervise external pharmacovigilance vendors.
• Ensure compliance with regulations and guidelines.
• Develop periodic safety reports for regulatory submissions.
• Lead discussions on reportable events.
• Participate in the Global Safety Database implementation.
• Support signal detection activities and compliance audits.
• Collaborate with cross-functional departments.
• Assist in the creation of safety-related SOPs.
• Perform other assigned Drug Safety/PV duties.

Requirements

• BS in life sciences/pharmacy/nursing or related field required.
• 10 years drug safety/pharmacovigilance experience.
• Knowledge of US and ex-US pharmacovigilance regulations.
• Experience with drug safety case processing.
• Ability to manage multiple vendors.
• Prior experience in safety data reports oversight.
• Excellent communication and organization skills.
• Advanced degree preferred.

Benefits

• Work in a rapidly growing company.
• High-impact contributor role.
• Collaborative work environment.
• Opportunity to implement process improvements.
• Engagement in regulatory compliance efforts.