Director Safety Operations & Quality Management

Description

The Director, Safety Operations & Quality Management reports to the Vice President, Drug Safety and oversees global safety operations and quality management activities. This role manages safety vendors and leads the coordination and delivery of safety outputs including aggregate reports in alignment with SOPs, guidelines, and global pharmacovigilance regulations. The Director will collaborate effectively across all organizational levels as well as externally with vendors and corporate partners.

Requirements

Responsibilities (including but not limited to):

• 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

Education/Experience/Skills:

• Master's or bachelor's degree in life sciences or related field (Registered Nurse- RN, Doctor of
• Pharmacy- PharmD, or Physician Assistant- PA preferred)
• 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
• Rare disease experience preferred
• Subject to extended periods of sitting and/or standing, vision to monitor and moderate noise levels. Work is generally performed in an office environment
• 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)

Catalyst is committed to providing competitive wages and comprehensive benefits including health, dental, and vision insurance, generous paid time off, a retirement savings plan with Company Match, and more. Further details about our benefits package can be found here: https://www.linkedin.com/company/catalystforrare/life/life-at-catalyst/?viewAsMember=true

The base salary for this position will range from $187,000 to $200,000. Candidate experience, professional licensing, and geographic location will be taken into consideration.

EEO Statement

Catalyst Pharmaceuticals is an Equal Opportunity Employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status.

Recruitment & Staffing Agencies: Catalyst Pharmaceuticals does not accept unsolicited agency resumes. Agency resumes will only be accepted if the agency is formally engaged by Catalyst Human Resources.