Pharmacovigilance Leader, Global Pharmaceuticals

Activities may include, but not limited to:

• Case processing: completion of full case information on the database, including quality review to ensure accuracy and completeness
• Triage of incoming cases to prioritize for daily workflow management
• Completion of remaining case data entry (including narrative or auto-narrative), manual
  coding, label and approval
• Preparation of SUA summary: Analysis of Similar Events Perform quality review of ICSR which includes review of source documents and ensuring that the case is accurate and that corrections to the case, if applicable, are
  incorporated
• Liaison with Case Receipt and/or Safety Surveillance Physicians (SSP) staff as appropriate to clarify appropriate information required for case processing
• Other activities relating to case processing as appropriate per case, including but
  not limited to:
• Single case & end-of-study; unblinding, SAE/AE reconciliation, deviation memo preparation, deletion/admin edit requests and approvals, review protocol update request forms for accuracy
• Supervising product-specific daily workload: prioritization and organization of team workload to maintain regulatory compliance and quality standards
• Review managers Daily Report(s) to prioritize and ensure compliance with processing
  timeframes
• Review regular Edit Check reports to identify processing inconsistencies and errors
• Monitor Aggregate Reporting Calendars to ensure cases are processed in required
  timelines
• Processes & procedures: awareness of and input to company procedures and guidance
• Completion of all assigned training on company and GMSO procedural documents relating to
  case processing
• Completion of training relating to relevant PV Agreements for assigned products
  Project work: participation in assigned projects, including inspection/audit readiness activities
• Participation in local or global project teams, including on-time delivery of assigned
  responsibilities
• Participation in inspections and audits as identified, including interviews and provision of
  requested data
• Assistance in preparation or implementation of corrective/preventative actions relating to
  case processing
• Mentoring & supervision: Mentoring of Case Processing (or other identified) staff, and involvement in recruitment and supervision.