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Manager, Pharmacovigilance

5+ years
Not Disclosed
10 Jan. 15, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Manager, Pharmacovigilance- Systems

Location: Global
Job Function: Pharmacovigilance (PV) Systems

ICON plc is a world-leading healthcare intelligence and clinical research organization. We are seeking a Safety Technology Lead (STL) within the PVSS / SRG group to manage the global interface for ICON Safety Systems. This role focuses on supporting Argus and Safety Reporting System (SRS) user communities, offering expertise, training, and project management across user requirements, database setup, testing, maintenance, and migrations.

Key Responsibilities:

  • Serve as the main point of contact for PV systems projects, ensuring project completion on time, within budget, and in line with quality standards.
  • Gather and document user requirements for ongoing projects related to ICON safety databases (Argus & SRS).
  • Provide system expertise to internal and external users, assisting with issue resolution and database configuration.
  • Guide User Acceptance Testing (UAT) and act as the Subject Matter Expert (SME) for the Safety Team.
  • Ensure audit readiness and represent PV Systems at audits.
  • Collaborate with IT teams and cross-functional departments to implement system/process improvements.
  • Manage project timelines, budgets, and deliverables, maintaining communication with sponsors and stakeholders.
  • Document processes for database setup, updates, data migrations, and other activities.
  • Mentor and support the systems team while overseeing resource management and business development.

What ICON Offers:

  • Competitive salary and a range of health and well-being benefits, including global insurance offerings, retirement planning, and life assurance.
  • Flexible benefits including childcare vouchers, gym memberships, and subsidized travel passes.
  • Global Employee Assistance Programme, offering 24/7 support for well-being.
  • A diverse and inclusive environment fostering high performance and innovation.

Qualifications:

  • Proven experience in PV systems, including Argus & SRS.
  • Expertise in gathering user requirements, documenting processes, and supporting database configurations.
  • Strong project management and leadership skills.
  • Knowledge of regulatory requirements and audit readiness.