Case Management - Manager

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Job description

Summary:

Act as US/EU local safety office and FDA/EMA point of contact for safety reporting

Submission of all individual case safety reports to FDA/EMA, business partners (license partners) and vendors

Support interactions with, business partners (license partners) and vendors for all case intake and processing activities

Vendor oversight of all case intake processing activities and case quality including analysis and reporting of trends in quality measures

Ensure vendor compliance with approved processes and training requirements

Audit & external inspection support

Responsible for:

Support ICSR processing to ensure high quality cases in a timely manner to meet all worldwide regulatory authority requirements

Provide vendors with resources and training to perform their role

Support the analysis and communication of case QC results

Lead development and delivery of training materials for case management conventions

Support resolution of case related specific queries

Management of multiple business partner relationships for case management

Support reviews of contract wording for case related data exchange

Monitoring compliance in regard to regulatory submissions and/or contractual wording for data exchange

Assign tasks within Case Management to direct and indirect reports

Support management of staff within Case Management

Escalation of case processing issues

Audit & external inspection support

Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness

Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility

Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by his/her supervisor

Key Activities:

Day-to-day vendor management issues

Interact with other local safety offices

Ensure case processing timelines for AE intake, triage and submission are met

Assess workload to assist in resource management

Support on-boarding and on-going training of vendors

Attend management meetings with vendors

Support analysis of QC trends

Support generating, communicating, and archiving of reports of QC findings

Support audits of CAPAs and other actions/recommendations for ICSR quality related measures

Perform case review as required

Lead development and delivery of convention-related training material

Support training of local office staff

Perform US case follow up activities

Perform BP reconciliation as required by safety agreement

Generate and distribute performance metrics (submission compliance, volumes, turnaround times)

Support reviews of contract wording for case related data exchange

Support regulatory inspection and support for vendor audits/inspections

Oversee performance monitoring and relay metrics to vendors

Support analysis of QC trends including actions/recommendations

Generate, communicate, and archive report of QC findings

Education & Experience (Basic)

Master's degree and 3 years of directly related experience OR Bachelor's degree and 5 years of directly related experience OR Associate's degree and 10 years of directly related experience OR High school diploma / GED and 12 years of directly related experience AND Previous experience directly managing teams, projects, programs or directing the allocation of resources

Top Must Have Skill Sets:

Understanding of global regulatory requirements for pharmacovigilance

Project leadership experience

Competence in safety systems

Experience in supporting inspections or internal audits

Microsoft Suite: Word, Excel, PowerPoint, Project, Outlook

Compensation:

The pay rate range above is the base hourly pay range that Aditi Consulting reasonably expects to pay someone for this position (compensation may vary outside of this range depending on several factors, including but not limited to, a candidate's qualifications, skills, competencies, experience, location and end client requirements).

Benefits and Ancillaries:

Medical, dental, vision, PTO benefits and ancillaries may be available for eligible Aditi Consulting employees and vary based on the plan options selected by the employee.

Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions.

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