Capricor Therapeutics, Inc.

Senior Director – Pharmacovigilance

Capricor Therapeutics, Inc.

full-time

Posted on:

Location Type: Hybrid

Location: San Diego • California • 🇺🇸 United States

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Salary

💰 $250,000 - $325,000 per year

Job Level

Senior

About the role

  • 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.

Requirements

  • 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.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
pharmacovigilancedrug safetyrisk management plan (RMP)pharmacovigilance system master file (PSMF)signal detectionsafety data monitoringsafety reportingsafety database implementationquality management systemregulatory compliance
Soft skills
leadershipcommunicationcollaborationindependencemulti-taskingtime managementpresentation skillsteam successcontinuous improvementproblem-solving
Certifications
Bachelor's degree in health scienceMDPharmDPhDICH certificationcGMP certificationFDA compliance trainingpharmacovigilance certificationdrug safety certificationregulatory affairs certification