Senior Director of Pharmacovigilance

Join to apply for theSenior Director of Pharmacovigilancerole atCapricor Therapeutics, Inc.1 day ago Be among the first 25 applicantsJoin to apply for theSenior Director of Pharmacovigilancerole atCapricor Therapeutics, Inc.Get AI-powered advice on this job and more exclusive features.Capricor Therapeutics, Inc. provided pay range This range is provided by Capricor Therapeutics, Inc.. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.Base pay range $250,000.00/yr - $325,000.00/yrCapricor (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. At the forefront of our innovation isDeramiocel(CAP-1002), our lead cell therapy in late-stage development for Duchenne muscular dystrophy. We are also harnessing our proprietary StealthXTM 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.ResponsibilitiesDesign, implement, and manage a robust, compliant, and scalable global pharmacovigilance system, including policies, procedures, and infrastructure suitable for cellular therapy productsDevelop 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 sectionsSelect, onboard, and oversee pharmacovigilance operations vendors and safety database providers to ensure high-quality case management, reporting, and regulatory complianceDirect 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 studiesLead signal detection and management processes, ensuring periodic review and updates to the RMP and PSMFOversee and review aggregate safety reports (e.g., PSURs/PBRERs, DSURs) for submission to global health authoritiesServe as the pharmacovigilance lead during health authority inspections (e.g., FDA, EMA) and internal auditsCollaborate 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 reportingChair and lead the internal Safety Review Team (SRT) for ongoing evaluation of product benefit-risk profilesInterface with vendors such as PPD and Syneos, clinical trial teams, CMO, and commercial partners to prepare safety documentation and oversee post-marketing clinical safety surveillanceWork cross-functionally to drive business impact, team success, and continuous improvement in pharmacovigilance operationsMonitor emerging safety data, regulatory trends, and therapeutic advancements in rare diseases and biologics to inform strategyPerform such other duties as may be assigned from time to timeRequirementsBachelor'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 roleMandatory prior experience successfully preparing for and executing the launch of a novel therapeutic product, preferably in the US and EU marketsDeep 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 systemExceptional written and verbal communication skills, capable of presenting complex safety data to regulatory authorities and internal stakeholdersStrong understanding of regulatory compliance, including cGMP, ICH, and FDA guidelinesAbility to work independently, multi-task, and meet aggressive deadlines in a fast-paced, resource-constrained environmentWillingness to travel up to 20-30% for inspections, meetings, and collaborationsProficiency in Microsoft Office suite (Word, Excel, PowerPoint)Equivalent combination of education and experience may be consideredPreferred QualificationsExperience with cellular or gene therapy products, or other complex biologics/rare diseasesAbility to transition between strategic planning and hands‐on operational execution in a small biotech environmentDemonstrated ability to lead complex safety issues and make sound, timely decisions regarding patient safety and regulatory complianceWork Environment & Physical DemandsProfessional office environment (San Diego, CA) or remote work setup with standard business hours, subject to flexibility for global interactionsAbility to sit for extended periods during virtual or in-person meetings and computer workOccasional travel requiring mobility, such as walking through conference venues or site visitsWhy Capricor? Capricor Therapeutics, a trailblazer in cell and exosome therapy, is dedicated to redefining standards of care with innovative treatments rooted in scientific excellence. Guided by integrity and a passion for patient-centered impact, our team is shaping a brighter future for healthcare. Join us and contribute to a mission-driven group that'S transforming lives with every breakthrough.Come Work With Us! At Capricor, you'll thrive in a collaborative environment that nurtures your professional growth and innovation. Join a dedicated team fueled by a passion for advancing medical science and transforming patient lives through our cutting‐edge therapies.Please note that Capricor does not use Skype for interviews or recruiting activities. Candidates will only be contacted by an official Capricor email address which is @capricor.com. Additionally, Capricor will never ask potential employees to send a check or money to the Company for any reason.Capricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third‐party recruiters without expressed consent from Talent Acquisition management and a prior written agreement. Agencies that contact hiring managers directly, solicit business, or submit candidates without this approval will not be considered for any engagement. All such submissions become the property of Capricor Therapeutics, and no fees will be paid for any candidates hired as a result. We appreciate your cooperation and respect for this policy.#J-18808-Ljbffr