Senior Safety Expert – Multiple European Locations (Frankfurt)

Job Description Join us on our exciting journey!IQVIA™ is The Human
Data Science Company™, focused on using data and science to help
healthcare clients find better solutions for their patients. Formed
through the merger of IMS Health and Quintiles, IQVIA offers a
broad range of solutions that harness advances in healthcare
information, technology, analytics and human ingenuity to drive
healthcare forward.https://www.iqvia.com/We are expanding the team
in Tarius, part of the IQVIA’s Global Market Insights (GMI)
division. Tarius databases is an on-line, subscription based
regulatory information provider to the global pharmaceutical and
device industries, helping companies stay on top of Regulatory
requirements. Tarius is IQVIAs on-line platform compiling reliable
and up-to-date global regulatory information from more than 110
countries, regions, and international organizations. Tarius
supports pharmaceutical and medical device companies by providing
access to up to date and comprehensive original and translated
regulatory documents, expert country summaries, tabulated
comparative regulatory information covering operational details and
timely alerts and state of the art
functionality.http://www.tarius.comSenior (Regulatory)
Safety/pharmacovigilance expert to join an expanding team of senior
experts in Tarius (on-line platform). Your roleYou 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
TeamThe 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
contentOwns (in partnership with the content manager) the safety
regulatory content in Tarius including the relevant expert
summaries and cross country tables covering all
countriesResponsible for ensuring the content quality standards are
met at all timesResponsible for providing high-quality impact
assessment of key regulatory safety/pharmacovigilance documents EU
and USCollaborates with Local experts and Tarius Editorial Team on
aspects related to the safety/pharmacovigilance regulatory
contentResponsible for knowledge-sharing and training within the
safety/pharmacovigilance regulatory areaMay participate in client
meetings as subject matter expert on the safety/pharmacovigilance
regulatory contentRequired 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 requirementsRisk management and qualified person
for pharmacovigilanceAbility to assess impact of new regulatory
requirements EU and USMaster’s degree or equivalentExcellent
English skillsExperience in working in a project settingKnowledge
of the pharmaceutical industry and its challengesBusiness
understanding/acumenAbility to create strong working relationships
across organisation (local experts, editors, consultants and
external partners)Key CharacteristicsProactive, Detail oriented,
knowledgeable, consultative, problem solver, customer focused,
creative, resourceful, fast & flexible, team player,
organizedIQVIAFORTUNE Magazine’s World’s Most Admired Companies
list for the third year in a rowRecognised by the 2016 Scrip Awards
as the Best Full-service Provider Contract Research Organization
(CRO).Awarded the 2016 Eagle Award from the Society for Clinical
Research Sites (SCRS) for the 4th consecutive year. A
site-nominated award recognising contract research organizations
(CRO) and biopharmaceutical sponsors dedicated to building positive
relationships with research sites through leadership,
professionalism and integrityIQVIA™ named in The International
Association of Outsourcing Professionals (IAOP) 2017 Global
Outsourcing 100® List which recognizes the world’s best service
providers across a range of industriesWe know that meaningful
results require not only the right approach but also the right
people. Regardless of your role, we invite you to reimagine
healthcare with us. You will have the opportunity to play an
important part in helping our clients drive healthcare forward
andWhatever your career goals, we are here to ensure you get
there!We invite you to join IQVIA™.IQVIA™ is an equal opportunity
employer. We make employment decisions based on qualifications and
merit. We prohibit discrimination based on any unlawful
consideration such as age, race, national origin, gender or other
„protected status.“Job ID: R1040362