Category: Scientific & Clinical
Job Title: PV Operations Associate
Contract Length: 12 mos
Number of Openings: 2
The PV Operations Associate provides operational support to the Clinical and Vendor Oversight teams to ensure proper performance of baseline PV compliance based responsibilities. This is done through implementation and regulation of global process, local legislation, case investigation, and study management. Responsibilities are performed under the direction of the PV Operations manager.
- Perform Individual Case Safety Reports (ICSR) tasks
- 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.
- Performs daily workflow coordination and initial review of cases that are processed by our internal teams
- Oversee the enrollment process and proper onboarding of GVP vendor
- Assists in the tracking and investigation of case processing related metrics
- 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 and assessed by PV Clinical Group
- Partners with key stakeholders to ensure proper assessment and documentation of study related decisions
- Supports MAP Operational 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 member and/or vendor leads to ensure appropriate follow-up is completed.
- Performs 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, and management of new assessments.
- 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.
- 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.
- Member of the Late Case Investigation Team
- Ability to review late case to determine reasoning and RCA/CAPA action needed
- Provide regular status updates, highlight potential risks and escalate issues to Team Leads and PV Operation 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.
- Vendor Oversight
- 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
- Tracks status of metrics and escalates to PV Operations Manager as required
Additionally, the PV Operations Associate will be accountable for the following;
- Ability to identify potential business gaps and assist 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 metrics as required
- Identifies compliance trends and formulates action plans as needed to address compliance issues
- Act as subject matter expert/point of contact for any audit/inspection related activities
Competencies Identified for Success:
- 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.
Education, Experience, and Other Requirements:
- Minimum Bachelor’s degree (Preferred) or 2-5 years PV experience.
- Degree in Life Science or related field (Preferred)
- Demonstrates expertise in computer skills and database experience (i.e. Microsoft office Suite) (Preferred).
- Writing experience; science/medical writing highly desirable.
- Ability to travel as required