(Archived) PV Signal Detection Manager

The role of Pharmacovigilance Signal Detection Manager is responsible for all aspects of the global signal management program, including but limited to: working closely with global pharmacovigilance team members, ITS Business Partner and the global adverse event database to build and drive the strategy, management, maintenance, user access, training program (including instruction guidance), and signal detection evaluation activities. In this role, you will be expected to spend a significant amount of time independently: organizing, analysing and evaluating data in support of signal management.

Education and Experience Desired:

A minimum bachelor’s Degree in Statistics, Chemistry, Animal Sciences, Pharmacy or Veterinary Medicine. Extensive working knowledge in statistics required. Knowledge or experience of Regulatory Affairs databases and veterinary medicines and vaccines preferred. At least 2-5 years of experience working in Veterinary / Human Pharmaceutical environment a plus. The successful candidate will have experience working in a dynamic multicultural environment and in a fast-paced environment.

Core Responsibilities include but not limited to:

• Act as Signal Management Subject Matter Expert
• Lead implementation of overall signal management surveillance strategy
• Develop routine and ad hoc signal evaluation process
• Explore signal detection methodologies, tools and data to further enhance pharmacovigilance safety surveillance program
• Provide guidance on methods of data mining and signal detection analysis

  Core Activities include but not limited to:

• Develop and implement product/species surveillance plans
• Perform signal detection activities including signal validation for adverse events and product quality issues
• Communicate and escalate emerging signals to leadership
• Establish criteria for CAPA related activities associated with signal management
• Build educational materials and procedures
• Execute signal detection training sessions
• Calculate and report routine Global Pharmacovigilance metrics

  Desired Skills

  • Demonstrate capability to comprehend, and analyze data and information
  • Work effectively, independently and collaboratively
  • Possess working knowledge of Global, Signal Detection Regulations
  • Strong organizational skills, detail oriented and adapts in a fast paced, changing environment
  • Demonstrates ownership, initiative, and accountability
  • Knowledge of statistics and/or system analytics
  • Ability to present complex data in a concise, scientific manner
  • Strong attention-to-detail