Associate Director / Director, Drug Safety Operations

San Diego, CA

  • Samumed is currently looking for a talented Associate Director / Director, Drug Safety Operations to join its team.
  • This position will report to the Vice President, Drug Safety & Pharmacovigilance (DSPV) and will provide  leadership and direction to the DSPV department for adverse event case management, oversight of maintenance of drug safety vendors, safety compliance and inspection readiness, and cross functional collaboration to support risk management and pharmacovigilance activities for the entire Samumed clinical development program.
  • S/he will provide pharmacovigilance oversight for Samumed’s DSPV quality management system and controlled documents, PV compliance and inspection readiness, PV vendors, key performance indicators and quality metrics.
  • The title will be dependent upon experience.
  • This position is based in Samumed’s San Diego-based headquarters.

Specific Responsibilities

  • Managing preparation, processing, and reporting activities of SAE reports for all Samumed investigational drugs
  • Reviewing incoming serious adverse events to determine action required
  • Overseeing maintenance of a hosted electronic database for tracking, storing, and reporting serious adverse events from Samumed clinical trials
  • Tracking due dates for regulatory submissions
  • Providing oversight of regulatory submissions to ensure compliance with regulations, data reconciliation of the safety and clinical databases for serious adverse events
  • Providing vendor oversight of case management for ICSRs and aggregate reports activities, compliance with regulatory submissions, development and review of KPI’s, compliance reports, and quality metrics for ICSRs
  • Working with department head to ensure PV compliance and inspection readiness
  • Providing oversight to the quality management system for pharmacovigilance, authors SOPs and WIs, and performs ongoing review of safety data quality and integrity via a QC process
  • Providing oversight for the compilation of safety information for aggregate safety reports and periodic safety reviews
  • Ensuring corporate compliance with domestic and international adverse event reporting requirements for all products in worldwide development program
  • Leading preparation of safety-related plans with partners and CROs
  • Training staff and external CRO's on drug safety principles and procedures and safety-related plans
  • Providing guidance and support to project teams for safety-related areas, including protocol development and study
  • Collaborating to ensure alignment among case handling, aggregate reporting, and signal detection activities

Requirements

  • Advanced degree in life sciences, nursing, pharmacy, or medicine
  • 5+ years pharmaceutical industry drug safety experience
  • Working knowledge of and experience with international regulatory adverse event reporting requirements
  • Strong understanding of local and applicable global safety regulations, medical terminology, and drug development process
  • Experience with use of safety databases, preferably Argus Safety Database
  • Hands-on experience with adverse event case processing
  • Proven experience and effectiveness at training and mentoring drug safety staff
  • Excellent knowledge of MedDRA coding and WHO Drug coding
  • Ability to work independently, establish functional priorities and execute on goals
  • Excellent interpersonal communication skills and ability to work effectively as part of teams
  • Ability to multitask and prioritize under tight deadlines while providing attention to detail and high-quality work in a dynamic environment
  • Ability to be flexible, adapt to change, work independently, as well as experience working in a matrix environment
  • Proficient in Microsoft Office Suite (Word, Excel, PowerPoint), safety databases, email, internet, and smart phones

Please submit your resume or additional inquiries to apply@samumed.com. Please include the complete title of the position for which you are applying in the subject line of your email. Emails that do not include this information will be disregarded.