Associate Director, Operations Patient Safety and Pharmacovigilance

Role Summary

Associate Director, Operations Patient Safety and Pharmacovigilance. Responsible for safety operations and vendor oversight activities, including operational tasks, management support, and oversight of ICSR case processing and submissions performed by a vendor. Involves safety operations strategy across the portfolio, vendor oversight, compliance, inspection readiness, and training to support growth and expansion. Seeks a cross-functional, proactive, motivated candidate.

Responsibilities

• Support effective vendor management operational activities and participate in strategies for safety operations to ensure compliance and inspection readiness.
• Provide support and input to set up vendor relationships (e.g., business requirements, vendor selection, contract details, vendor oversight/safety management plans).
• Collaborate with head of safety operations and internal stakeholders on vendor contract changes, invoicing, usage reports, unit projections, and forecasted units for projects.
• Ensure the global safety database (Argus) supports department needs, including workflows and reporting/querying functionalities.
• Provide oversight of system and MedDRA updates in collaboration with the safety vendor.
• Support leadership and oversight in processing of serious adverse events (SAEs) from various sources (clinical trials, partner trials, investigator-sponsored trials, expanded access).
• Manage and oversee ICSR case management workflow activities with the safety vendor to ensure case quality, data exchange, and timely submission of expedited safety reports.
• Lead with safety operations SMEs to manage site query activities for SAEs.
• Collaborate with Safety Quality and Compliance to support vendor management and performance metrics review.
• Partner with Safety Quality and Compliance, cross-functional SMEs, Clinical Quality, and safety vendor to review quality events and identify CAPAs for late safety reporting and deviations.
• Provide Safety Operational support to clinical trial study teams as needed.
• Act as SME for Safety business owner for Rave Safety Gateway activities, including new study startups and in-stream configuration changes.
• Support oversight of safety mailbox, retrospective QC of ICSRs, SAE reconciliation, and safety data cleaning with cross-functional SMEs as needed.
• Collaborate with Safety Quality and Compliance and Clinical Quality to generate, review, and approve governing documents (SOPs, WIs, templates) and ensure implementation.
• Support process gap assessment and process improvement; ensure inspection readiness with Safety Quality and Compliance.
• Support global filing activities for product approval; serve as SME for internal audits and global regulatory inspections when required.
• Support recruitment, hiring, mentoring, and manage direct reports with performance evaluations.

Qualifications

• Bachelor‚Äôs degree in nursing, pharmacy, or other health care related fields.
• 6+ years in Safety and Pharmacovigilance in the pharmaceutical industry; 4+ years managing contracted safety vendors.
• Oncology experience preferred.
• Ability to create, evaluate, and maintain effective business processes; implement procedures, systems, and tools to maximize resources within Safety.
• Thorough knowledge of safety reporting in clinical and post-market settings.
• Strong knowledge of drug safety database systems, document management systems, QC tools, and MedDRA; operational expertise in ARGUS required.
• Proven ability to work in a dynamic, complex, fast-paced team environment.
• Expert knowledge of FDA, EMA, and Asia-PAC regulations and ICH guidelines.
• Excellent interpersonal, communication, analytical, and organizational skills.
• Ability to collaborate with cross-functional teams (Clinical Operations, Biometrics, Regulatory) and lead with strong people and project management.
• Track record of building high-performing teams.

Skills

• Safety operations management
• Vendor management and contract oversight
• ICSR and SAE processing
• Rave Safety Gateway and Argus administration
• MedDRA, regulatory guidelines, quality management
• Cross-functional collaboration and leadership

Education

• Bachelor‚Äôs degree as listed in Qualifications

Additional Requirements

• Physical requirements primarily office-based; standard office equipment use; occasional lifting up to 25 pounds