Support interactions with business partners (license partners) and vendors for all case intake and processing activities.
Vendor oversight of all case intake and processing activities and case quality including analysis and reporting of trends in quality measures.
Ensure vendor compliance with approved processes and training requirements.
Submission of all individual case safety reports to FDA/EMA, business partners (license partners), and vendors.
Act as US/EU local safety office and FDA/EMA point of contact for safety reporting. Provide audit & external inspection support.
Assist in assuring quality of Individual Case Safety Report (ICSR) processing globally for clinical trial and post-market cases processed by vendors
Ensure Vendors deliver high quality cases through metric management meet all worldwide regulatory authority requirements
Provide vendors with resources and training to perform their role
Analysis and communication of case Quality Control results
Responsible for escalation of case related issues from vendor(s)
Providing audit/inspection support for case management related activities, including liaising with vendors to provide support as applicable
Undertaking activities delegated by the Qualified Person for Pharmacovigilance (QPPV) as detailed in the PV System Master File and maintain a state of inspection readiness
May assist with Periodic Aggregate Safety Reports (PASR) processes and associated metrics throughout the product lifecycle as applicable
Other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by their supervisor Work within the Quality Management System framework including all applicable training and controlled documentation governing Pharmacovigilance processes
Ensure vendor case processing timelines for AE intake, triage and submission are met
Perform retrospective quality assurance of vendor processed cases
Day-to-day vendor management issues
Interact with other local safety offices as applicable
Support on-boarding and off-boarding of vendor staff
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
Generate and distribute performance metrics (retro QA / Case correction)
Support analysis of QC trends including actions/recommendations

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.

Basic Qualifications:

Doctorate degree and 3 years of directly related experience (OR)
Master's degree and 6 years of directly related experience (OR)
Bachelor's degree and 8 years of directly related experience (AND)
2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Skills:

Understanding of global regulatory requirements for pharmacovigilance

Proficiency in safety case processing

Expertise in all aspects of case intake and processing in multiple global safety databases

Experience in supporting inspections or internal audits

Communication skills and attention to detail

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