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PV Operations Associate I
Ref No.: 19-07663
Location: South San Francisco, California
PV Operations Associate
South San Francisco, CA

Provides operational support to ensure oversight and PV (Pharmacovigilance) compliance through implementation of the Global MAP process, local legislation for MAP and study management. Responsibilities are performed under the direction of the Head of PV Operations.

  • Supports all MAP Operations related activities
    • Perform reconciliation related activities for Market Research Patient (MAP) support programs and responsible for tasks related to MAP Global Tracking Tool (GTT) to ensure continuous data integrity.
    • Run operational metrics reports on a routine basis, identify follow-up's required, and work with the appropriate PV Operations head and/or vendor lead to ensure appropriate follow-up is completed.
    • Oversees operational aspects of US MAP Service Provider Qualification Process including: curation and upkeep of US MAP Service Provider qualification portal, ensuring consistency and fidelity of all Service Provider lists, management and assignment of new assessments to PV Operations head and/or vendor lead
    • Responsible for executing Source Data QC (SDQC) of in scope MAPs on a quarterly basis. This includes: a) Communication with MAP vendors; b) management of vendor conducting SDQC, including appropriate QC; receiving, QC and tracking data files.
    • Ensure all MRP and PSP programs documentation (including SP training, CTV, SDQC, contracts) are tracked in Tracking Tool ensuring continuous data integrity.
    • Provide support to business/functional partners by answering questions and providing advice on good MAP practices.
    • Act as point of contact in the region for all communications in relation to MRP and PSP including participation in regular MAP lead meetings and at regional Business Planning meetings.
    • Provide regular status updates, highlight potential risks and escalate issues to line manager.
    • Oversee and support implementation of CAPAs and support business units where required to determine appropriate CAPA to any findings and ensure effective closure in a timely manner.
    • Ensure any non-compliance or late ICSR from programs are identified and ensure deviations are filed in accordance with global processes.
  • Supports all study management related activities
    • Responsible for oversight, triage, and tracking of incoming study document review request
    • Responsible for performing Case Transmission Verification (CTV)
    • Ensuring all USMA studies have been reviewed by PV Clinical Group
  • Performs Outbound Submission and Tracking (OST) for literature ICSRs and submits relevant documentation to health authority
  • Able to identify potential business gaps and assists in the development and implementation of process solutions.
  • Assists or leads special projects as assigned by and under the direction of the Head of PV Operations and/or other Safety personnel.
  • Participates in the education of internal and external stakeholders in safety related activities.
  • Assists in the tracking and investigation of case processing related metrics as required
  • Identifies compliance trends and formulates action plan as needed to address compliance issues.
  • Act as SME point of contact for any audit/inspection related activities
  • Ability to translate complex data trends to actionable steps
  • Demonstrates strong business expertise related to PV environment
  • Works effectively, independently and collaboratively.
  • Strong organizational skills, detail oriented and adapts in a fast paced, changing environment.
  • Demonstrates ownership, initiative and accountability.
  • Excellent communication skills, both written and verbal.
  • Able to translate complex tasks and execute in a timely manner to ensure compliance
  • Ability to prioritize tasks in a timely manner.
  • Ability to interact effectively in a multifunctional, multidisciplinary team setting.
  • Sound decision making abilities as demonstrated by systematic gathering of information, appropriately assessing the complexity of issues, and prioritization of tasks in a timely manner within the scope of responsibility.
  • Ability to actively exchange knowledge and ideas.
  • Demonstrates leadership skills.
  • Minimum Bachelor's degree in Life Sciences with 2+ years of industry experience OR 12-15 years of PV experience with no degree
  • Demonstrates expertise in computer skills and database experience (i.e Microsoft office Suite) (Preferred).
  • Writing experience; science/medical writing highly desirable