Capricor Therapeutics, Inc. · 2 weeks ago
Senior Director of Pharmacovigilance
San Diego, CA
Full-time
Hybrid
Director/Executive
$250K/yr - $325K/yr
8+ years expCapricor Therapeutics, Inc. is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. They are seeking a Senior Director of Pharmacovigilance who will build the pharmacovigilance function and ensure high-quality safety processes while overseeing safety surveillance and vendor management.
BiotechnologyHealth CareMedicalTherapeutics
Responsibilities
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
Qualification
Required
Bachelor's degree in a health science field (MD, PharmD, 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, multi-task, and meet aggressive deadlines in a fast-paced, resource-constrained environment
Willingness to travel up to 20-30% for inspections, meetings, and collaborations
Proficiency in Microsoft Office suite (Word, Excel, PowerPoint)
Equivalent combination of education and experience may be considered
Preferred
Experience with cellular or gene therapy products, or other complex biologics/rare diseases
Ability to transition between strategic planning and hands-on operational execution in a small biotech environment
Demonstrated ability to lead complex safety issues and make sound, timely decisions regarding patient safety and regulatory compliance
Company
Capricor Therapeutics, Inc.
Capricor Therapeutics is a publicly traded (NASDAQ: CAPR) biotechnology company with a mission to develop groundbreaking therapies that make a meaningful impact on patients’ lives.
51-200 employees
H1B Sponsorship
Capricor Therapeutics, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (2)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$329.5MKey Investors
Nippon ShinyakuNational Institutes of HealthCalifornia Institute for Regenerative Medicine
2025-12-05Post Ipo Equity· $150M
2024-10-17Post Ipo Equity· $75M
2024-09-17Post Ipo Equity· $15M
Leadership Team
AJ Bergmann
Chief Financial Officer
Recent News
2026-01-09
MarketScreener
2025-12-17
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