• Senior Safety Expert Jobs in United Kingdom

  • Iqvia
  • United Kingdom, Uk
  • Save Job
  • 10 - 13 Years
  • Posted : above 1 month

Job Description:

IQVIA is The Human Data Science Company, focused on using data and science to help healthcare clients find

You will join a dedicated and experienced team of senior regulatory experts who together with the Content Manager are responsible for the high quality regulatory content of the Database In your role you will be responsible for the development of new content offerings within the Safety/pharmacovigilance area working as part of the offering development projects on an on-going basis As we are expanding the scope and improving the Safety/pharmacovigilance information our offering as well as adding impact assessments, you are responsible for creating Safety/pharmacovigilance intelligence content and insights of value to our customers You will also be responsible for the on-going maintenance of Safety/pharmacovigilance content in our offering This includes the overall responsibility for the Safety/pharmacovigilance regulatory content within Tarius as well as the Cross-Country Tables and Expert Summaries across all countries You will succeed with this part of the role by collaboration with our local experts As our Senior CMC/Manufacturing expert you will be responsible for ensuring knowledge-sharing across the Tarius team on appropriate topics as well as establishing a network to other Safety/pharmacovigilance experts in other parts of IQVIA

The team is based in Copenhagen but it is not required for you to work out of Copenhagen

Overview of Team

The senior safety/pharmacovigilance expert will be joining an expanding team of senior regulatory experts who together with the content manager are responsible for the high quality regulatory content of the Database The expert team is supported by a Global Network of Regulatory Experts consisting of more than 300 senior regulatory experts based worldwide The local experts review and update information from their respective countries, providing their knowledge about local best practices and interpretation of the national regulations In addition, the expert team works closely with the Multilingual Editorial Team, based in the Copenhagen office, responsible for updating Tarius online information database

Key Responsibilities

Drives the safety/pharmacovigilance content work in offering development projects expanding and improving the quality of the safety/pharmacovigilance regulatory content
Owns (in partnership with the content manager) the safety regulatory content in Tarius including the relevant expert summaries and cross country tables covering all countries
Responsible for ensuring the content quality standards are met at all times
Responsible for providing high-quality impact assessment of key regulatory safety/pharmacovigilance documents EU and US
Collaborates with Local experts and Tarius Editorial Team on aspects related to the safety/pharmacovigilance regulatory content
Responsible for knowledge-sharing and training within the safety/pharmacovigilance regulatory area
May participate in client meetings as subject matter expert on the safety/pharmacovigilance regulatory content

Required Knowledge, Skills and Abilities

10 years of experience within safety/pharmacovigilance regulatory area (preferably from pharmaceutical company)
In-depth knowledge on safety/pharmacovigilance Pre-marketing pharmacovigilance requirements (clinical safety requirements)
Post-marketing pharmacovigilance requirements
Risk management and qualified person for pharmacovigilance
Ability to assess impact of new regulatory requirements EU and US

Masters degree or equivalent
Excellent English skills
Experience in working in a project setting
Knowledge of the pharmaceutical industry and its challenges
Business understanding/acumen
Ability to create strong working relationships across organisation (local experts, editors, consultants and external partners)

Key Characteristics

Proactive, Detail oriented, knowledgeable, consultative, problem solver, customer focused, creative, resourceful, fast & flexible, team player, organized

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Consulting Services
Functional Area : Production/Manufacturing/Maintenance/Packaging
Role : Safety/ Health
Salary : As per Industry Standards
Deadline : 23rd Jan 2020

Key Skills:

Company Profile:


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