Summary of Position:

The PV Systems Solutions & Innovations 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 implementation and regulation of global processes, local legislation, case investigation, and study management. Responsibilities are performed under the direction of the Senior Manager, PV Systems Solutions of Operations & Innovations.

Key Accountabilities:

Perform Individual Case Safety Reports (ICSR) Activities
Performs Outbound Submission and Tracking (OST) for literature ICSRs and submits relevant documentation to health authority
Ensure any non-compliance or late ICSR from programs are identified and ensure deviations are filed in accordance with global processes
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
Oversees the enrollment process and proper onboarding of GVP vendor
Assists in the tracking and investigation of case processing related metrics
Supports Late ICSR Investigation and Risk Mitigation Strategy
Ability to review 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
Responsible for performing Case Transmission Verification (CTV)
Ensures all US Medical (USM) studies have been reviewed and assessed by the Patient Safety and Risk Management
Partners with key stakeholders to ensure proper assessment and documentation of study related decisions
Escalates compliance risks or issues to management when identified
Assists in the tracking and investigation of metrics as required

Supports MAP Operational related activities
Perform reconciliation related activities for Market Research Patient (MAP) support programs and responsible for tasks related to GoMAP to ensure continuous data integrity
Run operational metrics reports on a routine basis, identify required follow-ups, and work with the appropriate PV Systems Solutions and Innovations team 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
Ensure all MRP and PSP programs documentation (including Service Provider Training, CTV, SDQC, contracts) are tracked in GoMAPensuring continuous data integrity
Assists in the tracking and investigation of metrics as required


Vendor Oversight for Outsourced Pharmacovigilance (PV) Activities
Understand the vendor management framework and translate the requirements into reporting deliverables
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 Senior Manager, PV Systems Solutions of Operations & Innovationsas required
Communicates closely with cross functional teams within US PS to achieve the appropriate level of support to ensure oversight of outsourced activities
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

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

Additionally the PV Solutions Systems and Innovations Associate will be accountable for the following;

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


Competencies Identified for Success:

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
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.
Ability to actively exchange knowledge and ideas
Demonstrates leadership skills

Education, Experience, and Other Requirements:

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

This is the pay range that Magnit reasonably expects to pay for this position: $35.00/hour-$42.86/hour

Benefits: Medical, Dental, Vision, 401K (provided minimum eligibility hours are met)

Magnit has an ongoing commitment to the diversity and inclusion of all team members. We believe that embracing diversity leads to innovation and helps address the needs of the business. We welcome individuals from different backgrounds, experiences, and cultures to join our team. We value this diversity and strive to create an inclusive environment that celebrates these unique perspectives, allowing you to contribute to your full potential. Finally, but most importantly, we expect all team members to be treated with dignity and respect.

If you have a disability and need an accommodation in relation to the online application process, please email us at Roche.Accommodations@magnitglobal.com