Prothena

Director, Pharmacovigilance Safety Systems

US-CA-South San Francisco
Job ID
2017-1175
Category
Research & Development

Overview

The Director PV Safety Systems is responsible for providing technical leadership for the development, maintenance, and improvement of the applications, safety information systems and related processes of the Global Safety and Pharmacovigilance (GSPV) Department. This position works closely with the IT department in support of all Drug Safety Systems, vendors and reporting applications. This position is responsible for providing Argus-based systems support for Pharmacovigilance activities, including technical and programming support, interacting with end users on technical matters, facilitation of user requirements gathering, implementation of user requirements and acts as a technical expert for designing customized/complex database solutions, queries and reports.

Responsibilities

  • Provides safety user support and system administration to ensure continuity of reporting Support submission activities associated with expedited individual case safety reports (ICSRs) to Regulatory Authorities and distribution of ICSRs to business partners, as needed.
  • Partner with vendor to ensure the maintenance and management of the Pharmacovigilance safety system(s). This includes managing all the necessary configurations such as, user configuration, workflows, products & licenses, expediting rules, E2B reporting, etc.
  • Partner with IT in the maintenance of other Pharmacovigilance systems, including but not limited to: gateways, signal detection system, MedDRA, etc.
  • Partner with IT and vendors on the design, development, validation and testing of the configuration and functionalities of the drug safety database
  • Partner with IT to plan and prioritize system/application improvements according to user requests and business requirements.
  • Perform testing, validation and execution of E2B certification with partners and regulatory authorities.
  • Develop and maintain system SOP’s and Work Instructions.
  • Assist with the development of safety system training materials and delivers training to employees with user training, as requested.
  • Interact closely and frequently with GSPV colleagues and other departments to ensure the integrity and consistency of safety data.
  • Assist in the generation of complete and accurate periodic regulatory reports and ad-hoc reports, for various constituencies with an interest in the safety database.
  • Establish best practices for data retrieval and query generation to present safety data from various sources in support of signal detection, regulatory submissions or ad-hoc queries.
  • May perform other activities as assigned.

Qualifications

  • Bachelor's degree in computer science, bioinformatics or related field required. Demonstrated ability to work effectively with a sense of urgency in a dynamic, cross-functional matrix environment
  • Minimum of 7 to 10 years of progressive experience in Systems Management or Safety Data Management (Argus experience required)
  • 10 – 15 years’ experience in the pharmaceutical or biotechnology industries is preferred
  • Experience with electronic submissions of safety data to regulatory authorities
  • Experience working on IT projects, GXP and systems validation including documentation in a regulatory environment
  • Strong knowledge of pharmacovigilance terminology and system data entry conventions
  • Demonstrated technical, analytical and problem solving skills as they pertain to safety database systems
  • Broad knowledge of Pharmacovigilance Databases
  • Programming experience with SQL or sufficient demonstrated proficiency required
  • Experience with E2B software (e.g., Axway)
  • Experience with reporting tools such as Spotfire or Cognos/Business Objects
  • Prior Experience in Business Configuration in Argus preferred
  • Prior experience in creating custom database queries
  • Ability to interpret and follow regulatory guidelines
  • Demonstrated leadership and project management skills
  • Ability to communicate across all levels of the organization
  • Demonstrated ability to lead the analysis and resolution of complex problems

 

Competencies and Attributes:

  • Demonstrated leadership to drive results that are needed to achieve company objectives in accord with Prothena’s culture and core values – courageousness, creativity, selflessness and humor
  • Excellent written and verbal communication skills
  • Must demonstrate a keen attention to detail and timelines
  • Ability to manage 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
  • Excellent time management skills and a proven ability to work on multiple projects at any given time
  • Must be proficient in MS Office Suite

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