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Role

Oversees all labelling activities for specified APIs and collaborates with Client and/or IQVIA stakeholders, such as Global Labeling, PV, GRLs and the LOCs (Local Operating Companies) to ensure regulatory compliance for these APIs.

Responsibilities

• Provides labelling inputs as required for product withdrawals and in response

to health authority queries

• Performs CCDS & local labelimpact assessments on receipt of a potential

signal or PRAC/HA recommendation

• Supports LOCs with local label implementation (E.g. basis label distribution,

preparation of m2.5s, review of Local product Information (PI))

• Maintains the Knowledge Transfer document for his/her API and ensures

smooth product handover during GLL transition.

• Completes all labelling deliverables within the required timelines

• Investigates specified APIs proposed for CCDS creation/revision/withdrawal

• Leads the CCDS/CDS (Core Company Data Sheet/Company Data Sheet) or CCSI creation/revision process and co-ordinates the

CCDS-working team (CCDS-WT).

• Leads the USPI (United States Prescribing Information)revision process and

co-ordinates the Labeling Working Group (LWG)

Authored reginal labelling documents(EU and US)

SPL(Structured Product Labelling

o Assesses labelling issues, including alignment with CCDS and

alignment to FDA Labeling guidance

Endorses Prescribing Information and Patient Information content prior

to final approval.

• Provides input to US Annual Reports

• Leads the EU SmPC and Patient Information Leaflet (PIL) creation/revision

process and co-ordinates the Labeling Working Group (LWG)

• Endorses SmPC and PIL prior to final approval

• Organises a back-up for planned absences.

• Keeps the Client Product Responsibility Listing (PRL) up-to-date for the

products for which he/she is the GLL.

• Operates to Client QMS documents and non-QMS documents for the

regulatory services provided.

• Proposes improvements to the current Client QMS procedures to the

RA Labeling Lead.

• Conducts quality control (QC) review for deliverables prepared by other GLLs.

• Raises suspected quality issues and process deviations with the RA

Labeling Lead.

• Escalates LOCs non-adherence to the Local exception forms, deferral request

form and RIM System ‘PRISM Data Entry Form (PDEF)’s in accordance with

the timelines and/or to submission timeline.

• Enters own labeling-related tasks in the IQVIA internal Project Management

tool.

• Reviews all open deliverables on a weekly basis and updates as applicable

• Updates the deliverables information and moves status to “Complete” when the deliverable is complete.

Qualifications

•  Bachelor Degree in Health Sciences or related field.

•  3 years of experience in US labeling activities: requirements, submissions, legislation, compliance. OR. 2-4 years of experience in local (own country or LATAM) labeling activities.

•  Advanced English: writing and speaking.

•  Be proactive, attentive to details, good command of communication, willing to learn things and be autonomous.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com