• Sr. Safety Specialist

    Job Locations US-CA-South San Francisco
    Job ID
    Research & Development
  • Overview

    This position is responsible for supporting ongoing pharmacovigilance activities pertaining to Prothena products.  The incumbent will serve as a safety database and pharmacovigilance subject matter expert; develop and/or contribute to department standard operating processes and procedures to ensure the uniform and timely processing of adverse event reports. This includes but is not limited to Argus case processing, adverse event case management, vendor oversight, generation of listings/reports, coordination and collaboration with other functional areas to ensure world-wide regulatory compliance while meeting Prothena objectives.


    • Provide subject matter expertise pertaining to the safety operations including but not limited to case intake, triage, data entry, quality review, queries, and report generation and submission.
    • Perform complete data entry of serious adverse events and generate accurate and complete case narratives based on information received from pre- and post-marketing data sources, according to the Prothena workflow processes and standard operating procedures.
    • Perform standard quality check of data entry of serious adverse events done by other safety specialists and/or vendors based on information received.
    • Perform follow-up and generate queries for outstanding information or incomplete data to ensure case completeness within acceptable timelines
    • Adhere to global regulatory regulations and reporting timelines for all expedited serious adverse events and for aggregate reports
    • Apply pharmacovigilance systems and regulatory knowledge to proactively manage and propose solutions to arising complex issues and problems by gathering, evaluating, and analyzing data
    • Manage CROs or contractor safety staff, as appropriate, to ensure that safety-related activities and project milestones are met within required timelines
    • Ensure complete and accurate case compilation through development of safety data collection forms and tracking reports, reconciliations of serious adverse events between the safety and clinical study databases, and summarization of serious cases for regulatory authorities and business partners, as applicable
    • Contribute to and develop standard operating procedures, guidelines, methods and techniques to aid in core safety operations processes and ensure regulatory compliance and consistency with industry standards
    • Maintain safety files and documentation that are compliant with regulatory requirements and consistent with the departmental and corporate document management systems
    • Function as a GSPV representative at cross-functional product team meetings as appropriate
    • Assist with coordination of case processing in preparation for aggregate report (DSUR/PBRER) data cuts.
    • Root cause analysis and investigation of issues related to case processing/coding, safety database and/or any other issues that impact case processing quality or timelines.
    • Assist with the GSPV metrics and quality plan, including execution of metric reports, creating summaries of metrics, identifying any possible issues, and creating a corrective action plan
    • Assist in maintaining Pharmacovigilance System Master File (PSMF)
    • Other related responsibilities and duties, as required by business need and/or assigned by GSPV Management



    • A Bachelor’s degree in a scientific discipline (e.g. Nursing, Pharmacy, Life Science) is required
    • At least 1-3 years of clinical experience in a patient care setting
    • At least 4 years of drug safety experience
    • Familiarity with Safety Databases; Argus experience preferred
    • Familiarity with Medical terminology required. Ability to process cases and perform MedDRA coding accurately
    • Solid knowledge of applicable domestic and international regulations/safety reporting requirements
    • Intermediate to advanced-level computer skills including word processing and safety database
    • Current professional licensure in the United States preferred, but not required


    Competencies and Attributes:


    • Demonstrated leadership to drive results that are needed to achieve company objectives in accord with Prothena’s culture and values – courageous, imaginative, selfless and joyful
    • Excellent oral and written communication skills – ability to effectively represent GSPV in various internal meetings
    • Focused and detail oriented
    • Self-starter and self-accountability
    • Ability to make effective decisions and manage several high-priority, fast-paced activities within required timelines Ability to create a quality work in a timely fashion, meeting reporting timelines
    • Ability to work independently with minimal supervision, but seek appropriate involvement from management regarding complex issues
    • Ability to be flexible and adapt to change




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