Global PV Strategy Leader — Senior Director

Braveheart Bio

San Francisco (CA)

On-site

USD 230,000 - 325,000

Full time

3 days ago
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Job summary

Braveheart Bio in San Francisco seeks a Senior Director, Pharmacovigilance to lead global drug safety strategy and operations. You will oversee PV governance, signal management, aggregate reporting, and vendor oversight across development programs and potential commercialization.

The role partners with the VP to scale the pharmacovigilance infrastructure, ensure regulatory compliance, prepare for Phase 3 submissions, and drive safety excellence in a fast-paced, international environment.

Qualifications

  • Senior-level pharmacovigilance leadership experience across global development and post-marketing environments.
  • Strong knowledge of global PV regulations and lifecycle safety.
  • Proven ability to author/oversee DSURs, PSURs, and RSI.
  • Experience with safety data exchange agreements and vendor oversight.

Responsibilities

  • Lead strategic and operational PV activities supporting development and future commercialization.
  • Oversee PV operations and compliance across the product lifecycle and reporting timelines.
  • Scale PV infrastructure, systems, and governance for Phase 3 programs and future launches.
  • Serve as SME for regulatory submissions, safety sections, and safety governance with partners.

Skills

PV Leadership
Regulatory liaison
Cross-functional collaboration
Signal detection

Education

MD/DO/PhD/NP/PharmD

Job description

Braveheart Bio in San Francisco seeks a Senior Director, Pharmacovigilance to lead global drug safety strategy and operations. You will oversee PV governance, signal management, aggregate reporting, and vendor oversight across development programs and potential commercialization.

The role partners with the VP to scale the pharmacovigilance infrastructure, ensure regulatory compliance, prepare for Phase 3 submissions, and drive safety excellence in a fast-paced, international environment.

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