Team Leader / Associate Director Case Management Operations

Reference Number: 895606-W
Type of placement: Permanent, Permanent
Location: Switzerland, Suisse Romande

Introduction:

One of our clients, a global pharmaceutical company, is currently looking for a Team Leader or Associate Director Case Management Operations.

Main Responsibilities:

  • Lead goal setting, Key Performance Indicators (KPIs) development and performance management within the International Case Management Operations team
  • Responsible for the definition and generation of metrics addressing work volumes, compliance, quality and productivity
  • Ensure team conformance with internal and external AE timelines
  • Oversee the daily flow of cases through Aris WF operating system
  • Support and contribute to the fulfilment of the company’s compliance with organized data collection programs conducted by other departments (i.e. Market Researches, PSP, etc.) including assisting with reviewing of project material across Haematology/Oncology and Immunology and Inflammation franchises
  • Provide leadership and oversight to ensure compliance with global, regional and local expedited reporting requirements
  • Ensuring optimal quality of case reports internally (e.g. EOI quality check) through monitoring and continuous improvement             
  • Contribute to identifying root causes, action items and action plans to correct quality issues stemming from internal or external review
  • Facilitate communication of quality and performance findings and cooperate with Safety Operations to address corrective and preventative actions as needed
  • Communicate with Trials Safety Team to identify and resolve SAE reporting issues
  • Supporting International Pharmacovigilance Operations
  • Collaboration with International Pharmacovigilance Operations Team and maintain effective level of communication and collaboration with Affiliate Pharmacovigilance Teams
  • Ensure timeliness and quality of processing of ICSRs to meet applicable data base locks for Aggregate Reports including PSURs, PBRER and DSURs across product franchises
  • Lead in the establishment and execution of Case Management projects in support of ongoing process evolution and improvement in line with internal and external drivers
  • Identify training needs of internal team as well as external customers & feeder groups
  • Contribute to Case Management Goal Setting
  • Execute Performance Management for Team
  • Participate in continuous improvement and supporting evolution and innovation within Case Management
  • Acts as SME for both internal audits and Regulatory Authority inspections

Qualifications and Experience:

  • Minimum 8 years pharmaceutical/biotechnology industry experience
  • Minimum 6 years Drug Safety experience
  • Minimum of B.Sc. or the equivalent combination of relevant education or professional experience
  • Team leadership experience is a must
  • Excellent knowledge of pharmacovigilance regulatory requirements (Safety and Risk management i.e. FDA, EMA and ICH guidelines)
  • Proficiency in technical safety systems including ARISg and medical coding
  • Knowledge of aggregate safety data utilization
  • Good project management skills
  • Excellent written and verbal communication skills including presentation skills
  • Ability to identify and communicate issues within department and across geographies
  • Stakeholder advocacy; promote open communication and build external relationships
  • Fluency in English written & spoken; French is considered an advantage
  • Relevant working/residency permit or Swiss/EU-Citizenship required

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