Catalyst Pharmaceuticals, Inc. · 12 hours ago
Director Safety Operations & Quality Management
Coral Gables, FL
Contract
Onsite
Director/Executive
$187K/yr - $200K/yr
8+ years expCatalyst Pharmaceuticals, Inc. is a company focused on drug safety and quality management. They are seeking a Director of Safety Operations & Quality Management to oversee global safety operations, manage safety vendors, and ensure compliance with pharmacovigilance regulations.
BiotechnologyHealth CareHealth DiagnosticsPharmaceutical
Responsibilities
Provide planning, implementation, and management of safety operations day-to-day activities
Lead vendor oversight and management for all outsourced or insourced Pharmacovigilance (PV) activities, from setup of the vendor relationships (e.g., business requirements, vendor selection, contract details, vendor oversight/safety management plans) to ensure inspection ready documentation of oversight
Manage Safety training, development, and compliance management
Partner with cross-functional colleagues including but not limited to Clinical Operations, Clinical Development, Quality, and partner collaborations in the generation, review, and approval of governing documents, such as Standard Operating Procedures (SOPs), Joint Operating Guidelines (JOGs), Operating Guidelines, Safety Data Exchange Agreements (SDEAs), and Safety Management Plans to ensure operational implementation
Ensure the Global Safety Database supports departmental needs, including specific workflows and reporting/querying functionalities
Provide oversight of systems and Medical Dictionary for Regulatory Activities (MedDRA) updates in collaboration with relevant vendors
Ensure timely submission of safety reports and other external submissions
Provide PV operation support to clinical trial study teams
Provide compliance monitoring/support and Key Performance Indicator (KPI) metrics generation and reporting
Manage Document Control Management (DCM) and inspection/audit readiness
Support management of Safety Deviations and Corrective and Preventive Actions (CAPAs)
Provide Pharmacovigilance System Master File (PSMF) development and management support as necessary
Collaborate with other key stakeholders to provide expertise and guidance for interdepartmental and cross-functional team activities, including process improvement standards and metrics
Serve as the Subject Matter Expert for Safety Operations and Quality Management during audits and inspections, ensuring compliance across case processing, literature monitoring, metrics reporting, and vendor oversight activities
Act as the primary Safety Operations & Quality Management contact within the company and across collaborations
Provide vendors with resources and training to perform their roles
Serve as SME in the development and maintenance of PV plans, including Safety Management Plans, Regulatory Reporting Plans, and Serious Adverse Event (SAE) reconciliation
Lead and/or maintain safety department project management activities including organizing safety team meetings, maintaining safety project timelines, taking meeting minutes, archiving safety-related documents, and maintaining team shared work folders and documents
Plan and assist in the preparation of aggregate safety reports such as the Development Safety Update Report (DSUR), Periodic Benefit-Risk Evaluation Report (PBRER), periodic line listings, safety assessments, and ad hoc analyses, as assigned
Support signal detection and risk management activities
Perform safety activities including SAE reconciliations, vendor reconciliations, oversight of submission compliance, case quality control (QC), and case closure
Oversee safety data exchange with corporate partners to ensure compliance with contracts and agreements related to safety case processing and reporting (e.g., SDEA)
Participate in inspections and audits, including inspection readiness activities
Support department initiatives on an ad hoc basis
Assist in the creation of Safety Operations-related training materials, Investigator and site training documents, authoring of Global Drug Safety (GDS) SOPs, and work instructions
Qualification
Required
Master's or bachelor's degree in life sciences or related field
Minimum of 8 years of pharmacovigilance experience at a biotechnology, pharmaceutical, or Contract Research Organization (CRO) company, with at least 6 years' hands-on experience in adverse event case management required
Experience in managing business partner/vendor relationships
Knowledge of Good Clinical Practices (GCPs), International Council for Harmonisation (ICH) guidelines, and U.S. Food and Drug Administration (FDA) regulations; familiarity with European Medicines Agency (EMA) regulations and other international regulatory requirements
Knowledge of MedDRA dictionary relevant to Adverse Event (AE)/Serious Adverse Event (SAE) coding
Experience with software-based drug safety systems (ARIS-G and/or Argus) required
Strong interpersonal and communication skills; proactive approach; able to work both independently and in a team environment
Detail-oriented, with good organizational, prioritization, and time management proficiency
Must be able to work on multiple projects simultaneously
Independently motivated, detail-oriented with strong problem-solving ability
Demonstrated problem-solving skills (including taking ownership to ensure timely resolution), a strong sense of urgency, keen attention to detail, and the ability to successfully execute in an environment under time and resource pressures
Proficient in standard computer software (Microsoft Word, Excel, and PowerPoint)
Preferred
Registered Nurse – RN, Doctor of Pharmacy – PharmD, or Physician Assistant – PA preferred
Rare disease experience preferred
Benefits
Health, dental, and vision insurance
Generous paid time off
A retirement savings plan with Company Match
Company
Catalyst Pharmaceuticals, Inc.
Catalyst Pharmaceuticals, Inc., (Nasdaq: CPRX) is a biopharmaceutical company committed to improving the lives of patients with rare diseases.
51-200 employees
H1B Sponsorship
Catalyst Pharmaceuticals, 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
2022 (1)
Funding
Current Stage
Public CompanyTotal Funding
$273.94M2024-01-05Post Ipo Equity· $140.1M
2017-11-27Post Ipo Equity· $53.6M
2015-02-03Post Ipo Equity· $34.7M
Leadership Team
Hubert E. Huckel
Co-Founder & Board of Directors
Michael W. Kalb
EVP & Chief Financial Officer
Recent News
2026-01-16
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