Manager Drug Safety & Pharmacovigilance, Operations

San Diego, CA

  • We are seeking a responsible, dynamic, creative and highly motivated Manager to join our Drug Safety and Pharmacovigilance team. 
  • The Manager provides scientific/clinical expertise in management of clinical and post-marketing Individual Case Safety Reports (ICSRs), management of SAE reconciliation activities, vendor management of relevant activities and PV compliance. 
  • The Manager also provides oversight of the Argus global safety database as subject matter expert (SME), workflow manager, and system administrator.
  • This is a full-time position in the company’s San Diego headquarters.

Specific Responsibilities

  • Act as system administrator for the Biosplice global safety database (Argus), including providing vendor oversight to the Argus cloud hosting provider, support for issue resolution, maintenance of safety database libraries, initiation of change control, system testing, as applicable, and training.
  • Provide operational leadership for ICSR workflow, overseeing the case management activities in Argus and ensuring critical timelines and compliance are met.
  • Perform case review, adverse event coding review, tracking of reports, and regulatory reporting activities to comply with protocol and global regulatory reporting timelines and specific requirements, as applicable.
  • Prepare for expedited reporting of SAEs, including supporting preparation of the analysis of similar events.
  • Monitor activities of CROs/business partners to ensure adherence and compliance with applicable Safety Monitoring Plans, other study plans, metrics, KPIs and contractual agreements.
  • Perform triage for incoming cases (assessing seriousness, listedness, and causality)
  • Serve as SME/lead for PV compliance and inspection and audit readiness for all Argus, workflow, KPIs, and case management- related topics.
  • Author high quality case narratives and collaborate on the development of analyses of similar events for the medical review of ICSR’s including identifying relevant information from source documents.
  • Ensure appropriate MedDRA and WHO Drug coding
  • Produce accurate safety reports (i.e., CIOMS/MedWatch Forms) for submission to regulatory authorities and partners.
  • Track due dates for regulatory submissions.
  • Provide oversight to reconciliation of the safety and clinical databases for serious adverse events, collaborating with data management and other stakeholders and follow up with sites to resolve discrepancies, as needed.
  • Conduct peer review of cases in the safety database for quality control (quality review step in the global safety database)
  • Generate safety queries as needed for clarification of clinical reports.
  • Conduct active case follow-up, including written and verbal follow-up with clinical investigators and sites.
  • Author SMPs and facilitate activities during project/study start-up phase, including cross-functional interactions.
  • Collaborates with Medical Directors, Clinical Operations, Regulatory Affairs, Data Management, Biostatistics, and PV Vendor’s clinical staff in providing pharmacovigilance support for ongoing clinical trials to ensure integration of safety data collection, review, processing, and reporting.
  • Review, update and maintain Data Entry Conventions, as applicable
  • Support the preparation of periodic safety reports (eg, DSUR, PADER) in accordance with regulatory requirements and standard operating procedures.
  • Support signal detection and evaluation activities in accordance with SOPs and guidelines.
  • Provide safety content review of protocols, study reports, Investigators Brochure, informed consents and other related documents, as applicable.
  • Support other pharmacovigilance activities, as needed.

Requirements

  • Bachelor of Science Degree or higher in a healthcare discipline (e.g. pharmacy, nursing)
  • 5+ years’ experience in drug safety/pharmacovigilance in a case processing role in the biotech/pharmaceutical industry in a CRO or pharmaceutical setting
  • Strong working knowledge of Argus Safety Database in an administration capacity
  • Vendor management experience preferred
  • Expertise in ICSR processing, including triage, data entry, quality review and submission.

Please submit your resume or additional inquiries to apply@biosplice.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. NO PHONE CALLS PLEASE.