Pharmacovigilance Operations Manager

The Pharmacovigilance Operations Case Management team acts as the US/EU local safety office and FDA/EMA point of contact for safety reporting. They do submissions of all individual case safety reports to FDA/EMA. The team supports interactions with, business partners (license partners) distributors and CROs for all case processing activities. They are responsible for vendor oversight of all case processing activities and case quality including analysis and reporting of trends in quality measures. They ensure vendor compliance with approved processes and training requirements. This team supports interactions with business partners (license partners), distributors and CROs for all case processing activities. They also provide audit & external inspection support.

Responsibilities include:

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) distributors and CROs
Support interactions with, business partners (license partners) distributors and CROs for all case processing activities
Vendor oversight of all case 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
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
Monitor workload for 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 reconciliation as required by safety agreement
Generate and distribute performance metrics (LNF, volumes, turnaround times)
Support reviews of contract wording for case related data exchange
Support regulatory inspection and support for vendor audits/inspections

Basic Qualifications:

Master's degree and 3 years of safety experience
OR
Bachelor's degree and 5 years of safety experience
OR
Associate's degree and 10 years of safety experience
OR
High school diploma / GED and 12 years of safety experience

Preferred Qualifications:

Previous managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Understanding of global regulatory requirements for pharmacovigilance

People or project management experience

Competence in safety systems and medical coding

Experience in supporting inspections or internal audits