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
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 & Tools
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