PV Signal Detection Manager

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Reference
PV Signal Detection Manager
Title
PV Signal Detection Manager
Job type
Permanent
Location
Zaventem (BE) / Kalamazoo (US)
Specialty
Chemistry and Pharmacy
Web site
Description

Zoetis is the leading animal health company, dedicated to supporting its customers and their businesses. Building on more than 60 years of experience in animal health, Zoetis discovers, develops, manufactures and markets veterinary vaccines and medicines, complemented by diagnostic products, genetic tests, biodevices and a range of services. Zoetis serves veterinarians, livestock producers and people who raise and care for farm and companion animals with sales of its products in more than 100 countries. For more information, visit www.zoetis.com

The role of Pharmacovigilance Signal Detection Manager is responsible for all aspects of the global signal management program, including but not 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

Our offer:

  • An innovative, international working environment with room for ownership & personal development.
  • An excellent remuneration package.

 

Organisation
Zoetis