Associate Director, Product Safety

Provide oversight of Global Product Safety Operations in support of monitoring safety profiles of all Cerus products, management and maintenance of spontaneous (post-market) and clinical trial reports in the Cerus Argus safety database.

Primary Responsibilities:

As a Product Safety Operations Lead

  • Accountable for management of Product Safety activities, including but not limited to:
    • Case processing of applicable clinical and post-market adverse event reports
    • Development and maintenance of Cerus safety database (Argus) including user training
    • Safety query generation, query tracking and resolution processes
    • Preliminary safety assessment to identify if a case report or a registered complaint has a (potential) impact to the health of a person
    • Review and approval of safety cases for medical review and submission by RA to regulatory authorities
  • Reconciliation of Clinical and Safety databases for active clinical trials where applicable
  • CRO and investigative sites safety reporting training, participate in investigator meetings
  • Cooperation between quality assurance and safety operations on activities resulting from customer feedback from post-market routine use and Cerus sponsored post-market studies

 

  • Generate and/or contribute to product safety- related SOPs (including SOP-related documents, processes and guidelines) in alignment with CRMA directives  
  • Manage product safety operations staff including training and employee development
  • In partnership with HR and a supervisor, manage product safety operations resourcing and budgets (e.g., vendors, and contract safety personnel)
  • Participate in/prepare for internal audits and regulatory inspections, including maintaining a state of inspection readiness
  • Manage Product Safety vendors and CRO Safety Specialists by ensuring delegated safety activities and respective invoicing are in alignment with applicable SOW
  • Generate or contribute to the preparation, dissemination, and presentation of safety-related information to the clinical team and investigative sites
  • Review and/or contribute to the safety sections to various clinical study-related documents
  • Prepare reports and listings to address inquiries from internal and external groups on product safety topics such as DSMB requests
  • Participate and contribute to study safety data analysis activities such as routine data review
  • Reviews/identifies potential safety issues, and escalates through the appropriate channels within clinical study team
  • Review/ approve safety reports for the global regulatory submissions and contribute to the safety sections of periodic or AdHoc submissions (e.g., periodic aggregate reports, responses to regulatory agency inquiries and expedited safety reports).
  • Assist Medical Affairs in generating listings for data updates and analyses of similar events , assist with analysis to senior management including signal detection and trend analysis activities
  • Assist Biostatistics with development of study tables or analyses where appropriate, including but not limited to SAE/TR listings, edit checks, weekly safety updates, etc.

Qualifications/Requirements/Skills:

                       

  • BS/BA or higher degree in Nursing, Pharmacy or other Life Science with adequate experience necessary to evaluate clinical data
  • Minimum 7 years of product safety or a combined product safety and clinical experience
  • Thorough working knowledge of safety databases (preferably Argus) and report generation
  • Knowledge of adverse event reporting requirements US and OUS ( Device experience a plus)
  • Knowledge of AE and drug coding conventions (MedDRA, WHO-DD)
  • Demonstrated people management and leadership skills
  • Strong interpersonal and organizational skills
  • Proficiency in MS Office Suite
  • Working knowledge of different EDC systems
  • Flexible in a fast-paced work environment; ability to adapt to changing priorities
  • Excellent oral and written communication skills
  • Ability to manage both day-to-day operations as well as project work in a fast paced environment
  • Ability to work both independently and in a collaborative team setting

 

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.