Global Pharmacovigilance Director, Safety & Strategy

Braveheart Bio; Oregon (WI); On-site; USD 230,000 - 325,000; Full time

Job summary

Braveheart Bio is seeking a Senior Director, Pharmacovigilance to lead global drug safety, surveillance, and regulatory compliance. You will oversee ICSR collection, DSUR/PSUR activities, risk management, and PV vendor oversight, aligning safety governance with co-development and licensing partners.

This role supports scaling operations from late-stage development to commercialization. You will partner with senior leadership to ensure robust safety governance, inspection readiness, and timely

Qualifications

• 10+ years in drug development with PV/safety focus
• Experience authoring aggregate safety reports (DSURs/PSURs) and RSI
• Experience supporting global regulatory submissions (IND/NDA/MAA) and safety queries
• Strong PV governance, vendor oversight, and risk management experience

Responsibilities

• Lead strategic and operational PV activities for Braveheart's development and future portfolio
• Oversee PV operations, compliance, and reporting timelines across product lifecycle
• Scale PV infrastructure, systems, and processes for Phase 3 and commercialization
• Provide safety data reconciliation, SDEA/PVA governance, and safety issue escalation

Skills

Pharmacovigilance

DSURs/PSURs

Regulatory submissions

Signal detection

Vendor management

Cross-functional

Global regulations

Education

Degree in Health Care

Job description

Braveheart Bio is seeking a Senior Director, Pharmacovigilance to lead global drug safety, surveillance, and regulatory compliance. You will oversee ICSR collection, DSUR/PSUR activities, risk management, and PV vendor oversight, aligning safety governance with co-development and licensing partners.

This role supports scaling operations from late-stage development to commercialization. You will partner with senior leadership to ensure robust safety governance, inspection readiness, and timely