Senior Director of Pharmacovigilance

Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. At the forefront of our innovation is
Deramiocel CAP-1002, our lead cell therapy in late-stage development for Duchenne muscular dystrophy. We are also harnessing our proprietary Stealth

X™ exosome platform to unlock new possibilities in targeted delivery and vaccinology. Every program reflects our commitment to pushing the boundaries of science and delivering life-changing treatments to patients and families who need them most.

Capricor is looking for a Senior Director of Pharmacovigilance with deep expertise within biotechnology, ideally in rare diseases or cell therapies. This role will play a pivotal part in building the pharmacovigilance function as we advance our lead programs following recent clinical milestones. This individual will ensure high-quality, compliant safety processes, oversee vendors and safety surveillance, and facilitate rapid communication of safety concerns.

This new headcount position supports our major milestone of positive Phase 3 results and continued advancement of deramiocel.

• Design, implement, and manage a robust, compliant, and scalable global pharmacovigilance system, including policies, procedures, and infrastructure suitable for cellular therapy products.
• Develop and lead pharmacovigilance activities essential for program progression, including creation of the Risk Management Plan (RMP), Pharmacovigilance System Master File (PSMF), and required safety labeling sections.
• Select, onboard, and oversee pharmacovigilance operations vendors and safety database providers to ensure high-quality case management, reporting, and regulatory compliance.
• Direct and execute global safety surveillance activities, including monitoring, evaluation, and interpretation of safety data from various sources such as spontaneous reports, literature, and post-approval studies.
• Lead signal detection and management processes, ensuring periodic review and updates to the RMP and PSMF.
• Oversee and review aggregate safety reports (e.g., PSURs/PBRERs, DSURs) for submission to global health authorities.
• Serve as the pharmacovigilance lead during health authority inspections (e.g., FDA, EMA) and internal audits.
• Collaborate closely with Regulatory Affairs on submissions and labeling, with Clinical Operations/Development for seamless safety transitions, and with Commercial and Medical Affairs teams to provide expertise and training on safety reporting.
• Chair and lead the internal Safety Review Team (SRT) for ongoing evaluation of product benefit-risk profiles.
• Interface with vendors such as PPD and Syneos, clinical trial teams, CMO, and commercial partners to prepare safety documentation and oversee post-marketing clinical safety surveillance.
• Work cross-functionally to drive business impact, team success, and continuous improvement in pharmacovigilance operations.
• Monitor emerging safety data, regulatory trends, and therapeutic advancements in rare diseases and biologics to inform strategy.
• Perform such other duties as may be assigned from time to time.

• Bachelor's degree in a health science field (MD, Pharm
  
  D, PhD, or equivalent preferred).
• Minimum of 8+ years of progressive experience in Pharmacovigilance/Drug Safety within the pharmaceutical or biotechnology industry, with at least 3 years in a leadership or management role.
• Mandatory prior experience successfully preparing for and executing the launch of a novel therapeutic product, preferably in the US and EU markets.
• Deep understanding of global PV regulations, guidelines, and ICH standards (e.g., FDA, EMA, MHRA, and other major health authority requirements).
• Proven experience in establishing or significantly contributing to the implementation of a validated safety database and PV quality management system.
• Exceptional written and verbal communication skills, capable of presenting complex safety data to regulatory authorities and internal stakeholders.
• Strong understanding of regulatory compliance, including cGMP, ICH, and FDA guidelines.
• Ability to work independently,…