Pharmacovigilance Assessor Jobs

Job Title: PV Operations Associate

Location: South San Francisco, CA (Local candidates to South San Francisco/Bay Area Only. On campus presence 3 days a week required)

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The PV Operations Associate provides operational support to the US Patient Safety Clinical and Vendor Oversight teams to ensure proper performance of baseline PV compliance-based responsibilities. This is done through the implementation and regulation of global processes, local legislation, case investigation, and study management. Responsibilities are performed under the direction of the PV Operations Manager.

Key Accountabilities:

● Perform Individual Case Safety Reports (ICSR) Activities

• Assists and collaborates with Global ICSR team to inform on US Affiliate ICSR compliance performance and risks
• Performs daily workflow coordination and initial review of cases that are processed by our internal teams
• Assists in the tracking and investigation of case processing related metrics
• Oversees the enrollment process and proper onboarding of GVP vendor
• Ensure any non-compliance or late ICSR from programs are identified and ensure deviations are filed in accordance with global processes
• Performs Outbound Submission and Tracking (OST) for literature ICSRs and submits relevant documentation to the health authority

■ Supports Late ICSR Investigation and Risk Mitigation Strategy

● Ability to review the late case(s) to determine root cause analysis (RCA) and corrective action preventative action (CAPA) as needed

● Provide regular ICSR compliance updates, highlight potential risks or trends and escalate issues to Team Leads and US PS Leadership Support implementation of CAPAs and business units where required on appropriate CAPA to any findings

● Continuous review of ICSR compliance trends to inform risk mitigation strategy to avoid non-compliance for the US affiliate

● Liaise and collaborate with vendor oversight teams to ensure external and internal stakeholder compliance

● Supports all study management related activities

• Responsible for oversight, triage, and tracking of incoming study document review request
• Escalates compliance risks or issues to management when identified
• Partners with key stakeholders to ensure proper assessment and documentation of study related decisions
• Responsible for performing Case Transmission Verification (CTV)
• Assists in the tracking and investigation of metrics as required
• Ensuring all US Medical Affairs (USMA) studies have been reviewed and assessed by PV Clinical Group

● Supports MAP Operational related activities

• Run operational metrics reports on a routine basis, identify required follow-ups, and work with the appropriate PV Operations member and/or Vendor Leads to ensure appropriate follow-up is completed
• Responsible for executing Source Data QC (SDQC) of in-scope MAPs on a routine basis. This includes a) Communication with MAP vendors; b) management of vendor conducting SDQC, including appropriate QC; receiving, QC, and tracking data files
• Perform reconciliation related activities for Market Research Patient (MAP) support programs and responsible for tasks related to GoMAPto ensure continuous data integrity
• Assists in the tracking and investigation of metrics as required
• Ensure all MRP and PSP programs documentation (including Service Provider training, CTV, SDQC, contracts) are tracked in GoMAPensuring continuous data integrity

● Vendor Oversight for Outsourced Pharmacovigilance (PV) Activities

• Support Lead on all operations performed, including training and the implementation of policies/procedures that ensure effective and compliant operations
• Develops agendas and facilitates meetings as needed
• Tracks status of metrics for outsourced activity and escalates to PV Operations Manager as required
• Leads or assists in the tracking, investigation and trending of case processing related metrics (e.g., late case investigation) including compliance-related issues set by the vendor management strategy team
• Understand the vendor management framework and translate the requirements into reporting deliverables
• Communicates closely with cross-functional teams within US PS to achieve the appropriate level of support to ensure oversight of outsourced activities

● PV Activity Classification and Promotional Review Material

• Oversight and review of approved Promotional Review Committee (PRC) promotional marketing materials for proper oversight of market research programs and patient support programs (MAP).
• Responsible for oversight of receipt and processing pharmacovigilance activity classification (PVAC) requests and/or safety-related queries.

Additionally, the PV Operations Associate will be accountable for the following;

• Act as a subject matter expert/point of contact for any audit/inspection related activities
• Ability to identify potential business gaps and assist in the development and implementation of process solutions
• Participates in the education of internal and external stakeholders in safety-related activities by creating and assigning required training
• Continuous evaluation of operational remit to assess process improvements, and opportunities to consolidate or outsource PV activities
• Project Management responsibilities, including the development and management of detailed project schedules and scope of work
• Assists or leads special projects as assigned by and under the direction of US PS Leadership

Competencies Identified for Success:

• Demonstrates strong business expertise related to the PV environment
• Works effectively, independently, and collaboratively
• Demonstrates leadership skills
• Ability to prioritize tasks in a timely manner
• Ability to interact effectively in a multifunctional, multidisciplinary team setting.
• Able to translate complex tasks and execute them in a timely manner to ensure compliance
• Ability to actively exchange knowledge and ideas
• Demonstrates ownership, initiative, and accountability
• Strong organizational skills, detail-oriented and adapts to a fast-paced, changing environment

Education, Experience, and Other Requirements:

• Minimum Bachelor’s degree (Preferred) or 5-10 years PV experience.
• Familiarity with project management software tools, methodologies, and best practices
• Excellent communication skills, both written and verbal
• Strong interpersonal skills and extremely resourceful
• Excellent analytical skills and ability to translate complex data trends into actionable steps
• Degree in Life Science or related field (Preferred)
• Ability to travel as required
• Proven ability to solve problems creatively
• Demonstrates expertise in computer skills and database experience (i.e Microsoft Office Suite and Google Applications ) (Preferred)
• 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