ADC Therapeutics

Senior Director, Global PV Operations and Safety Science

ADC Therapeutics

full-time

Posted on:

Origin:  • 🇺🇸 United States

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Job Level

Senior

Tech Stack

AssemblyJavaScript

About the role

  • Accountable for delivery of PV operation activities and ensuring timely and consistent execution globally
  • Manage and oversee PV vendor responsible for ICSR management (collection, processing, and regulatory reporting) including associated quality and training activities
  • Collaborate closely with stakeholders including PV partners (PVPs) to ensure operational deliverables are met
  • Ensure regulatory compliance with global regulatory authorities and submission compliance with PVPs
  • Provide vigilance expertise on operational processes to stakeholders (clinical development, clinical science, biometrics, data management, commercial)
  • Implement and maintain the PV QMS and ensure adherence to SOPs and best industry practices
  • Work with Quality Management personnel on PV QMS to develop or update PV SOPs/WI
  • Ensure awareness and training of Company personnel and external groups on PV principles, policies and SOPs
  • Lead, develop, negotiate, implement and maintain safety agreements (PVAs, SDEAs, SMPs) with PVPs and IITs
  • Drive and set safety performance standards within PV operations to ensure quality and compliance
  • Monitor vendor KPI, compliance metrics, invoice management, budget and quality standards for PV operations deliverables
  • Develop and implement operational sourcing strategies to optimize cost, capacity, quality and performance
  • Support audits & inspections, preparation of audit strategy, root cause analysis and CAPA development
  • Support/lead aggregate reports, signal and risk management activities and collaborate with safety physician on signal detection
  • Support preparation, quality control and compliance of aggregate safety reports (PBRER, DSUR, SASUSAR), REMS, RMPs, risk communications and regulatory responses
  • Collaborate with vendor, PVP and Regulatory to develop submission schedules for aggregate safety reports and regulatory submissions
  • Support preparation and review of safety sections of IB, protocols, informed consent forms, SAPs, clinical study reports, IND/NDA/BLA/MAA and renewals
  • Participate in investigator meetings to train site personnel in SAE data collection and reporting
  • Support safety physician in iDMC meetings and ensure safety data reconciliation between safety and clinical databases

Requirements

  • Bachelor’s Degree including a Health care degree (RN, Pharm D) or PhD in biomedical or pharmaceutical sciences
  • Extensive drug safety experience in oncology highly desirable
  • Minimum 10 years of PV operations experience within the biotechnology or pharmaceutical industry is required
  • Prefer management experience with direct reports
  • High EQ with demonstrated skills and experience fostering a positive culture within a PV organization
  • Expert knowledge of global PV requirements (US CFR regulations, EU GVP and ICH Guidelines)
  • Experience and extensive working knowledge of MedDRA and proprietary safety databases
  • Experience managing business process outsourcing vendors and relationships
  • Experience with Quality Management Systems (QMS) and the development of SOPs
  • Experience and extensive working knowledge of PV processes for individual case medical review, signal detection and evaluation, risk management, aggregate data assembly, review and report, as well as clinical study safety management
  • Experience with compilation, writing and reviewing safety documents such as DSURs, IB, PBRERs/PADERs, responses to Health Authority requests, submission documents and safety labels
  • Experience with audit and inspection
  • Proficient with Microsoft Office
  • Strategic thinking, strong organizational and analytic skills, project management, excellent verbal, written communication skills, attention to detail