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PV Signal Detection Manager

17/04/2019
- Zaventem

Job content

As a Pharmacovigilance Signal Detection Manager, you will be 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.   


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


Profile
  • minimum Bachelor’s degree in Statistics, Chemistry, Animal Sciences, Pharmacy or Veterinary Medicine
  • 2-5 years of experience working in Veterinary / Human Pharmaceutical environment a plus.
  • Extensive working knowledge in statistics required.
  • Knowledge or experience of Regulatory Affairs databases and veterinary medicines and vaccines is preferred.  
  • 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


Contact

For more information: Marieke Franken +32 16 30 95 09 or marieke@arcq.be. 

Contact
Marieke Franken +32 16 30 95 09