Senior Director of Pharmacovigilance
Capricor Therapeutics(1 month ago)
About this role
The Senior Director of Pharmacovigilance at Capricor Therapeutics will build and lead the global pharmacovigilance function in support of late-stage and commercial cell therapy programs for rare diseases. The role oversees design and governance of safety systems, processes, and documentation to ensure compliance with global regulations. It is a senior leadership position that interfaces extensively with regulatory agencies, internal stakeholders, and external partners as the company advances its lead therapy through and beyond Phase 3. The position may be based in San Diego or remotely with regular collaboration across global teams.
Required Skills
- Pharmacovigilance Management
- Drug Safety
- Risk Management Plans
- Safety Surveillance
- Signal Detection
- Aggregate Reporting
- Regulatory Compliance
- Vendor Management
- Safety Database Management
- Regulatory Submissions
+10 more
Qualifications
- Bachelor's Degree in Health Science
- MD
- PharmD
- PhD
About Capricor Therapeutics
capricor.comCapricor Therapeutics, Inc. (NASDAQ: CAPR) is a San Diego–based biotechnology company developing cell- and exosome-based therapeutics for muscular and other select diseases. Its lead candidate, deramiocel (CAP‑1002), is an allogeneic cell therapy currently in Phase 3 clinical development for Duchenne muscular dystrophy. Capricor is also advancing exosome technology as a next‑generation platform, engineering exosomes to deliver nucleic acids and proteins to treat or prevent a variety of diseases. The company focuses on translating these platforms into novel therapeutic and preventive products.
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