Senior Manager, Pharmacovigilance Submissions

3 days ago

Wilmington, Delaware, United States Incyte Full time
Job Summary

The Senior Manager, Pharmacovigilance Submissions will oversee the management of global ICSR submissions activities to ensure compliance with Incyte, global Regulatory Authority and Business Partner requirements. This role will ensure that the ICSR data elements transmitted to regulatory authorities meet global reporting requirements and company standards.

Key Responsibilities
  • Manage submission teams and oversee the submission of required global ICSR reports for Incyte marketed products and clinical trials.
  • Oversee the tracking and submission acknowledgement processing, including submissions failure notifications to ensure timely resolution of issues.
  • Participate in safety system configurations to ensure new project submission requirements and regulatory requirement changes are implemented by the operational and submissions teams as appropriate.
  • Participate in regulatory intelligence gathering and management.
  • Support the QPPV and Senior Management as required.
  • Represent Pharmacovigilance Submissions on intradepartmental, business partners, and vendor teams.
  • Provide in-depth technical expertise on global Pharmacovigilance submission processes and systems.
  • Oversee CAPA/audit or inspection finding investigations and compilation of data to support quality and compliance processes, including root cause analysis for submission issues.
  • Lead business continuity planning around global Pharmacovigilance submission processes.
  • Support audit and inspection processes as required.
  • Actively identify process improvement and efficiency needs and develop solutions as appropriate.
  • Develop procedures (SOPs, Job Aids), forms, and templates in support of efficient case submissions processes.
  • Complete resource management processes, including line management of assigned staff and succession planning.
  • Assist vendor manager with oversight of submissions vendor.
  • Develop supporting staff skills, encourage growth, and provide regular performance feedback.
  • Ensure compliance with internal procedures, regulatory requirements, and partner agreements to ensure inspection readiness at all times.
  • Maintain files and systems as appropriate.
Qualifications
  • Bachelor's degree in a science or healthcare-related discipline, or equivalent.
  • Minimum of 8 years pharmacovigilance experience or other equivalent clinical or pharmaceutical experience, with an additional 2 years' experience leading teams and 4 years submissions experience.
  • Safety database system expert (Argus required).
  • Advanced knowledge of global Pharmacovigilance regulations (CFR/GVP), ICH Guidelines, and Good Clinical Practices.
  • Excellent computer skills (i.e., Microsoft Word, Excel, Outlook, and Power Point).
  • Demonstrates accountability and responsibility for both management role and assigned team.
  • Expert organizational, time management, and problem-solving skills.
  • Proficiency with creating and delivering presentations.
  • Excellent verbal and written communication skills.
  • Fluency in written and verbal English.
  • Travel (domestic and global) 10%.
  • Ability to travel to office for monthly departmental meetings at assigned Incyte offices as well as for ad hoc meetings and/or urgent matters (notice period: 24 hours or less) as needed.

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