Johnson & Johnson Careers

IPV Regional Case Management Lead_EMEA

High Wycombe, United Kingdom
Drug & Product Safety Operations


Job Description

Requisition ID: 1905725211W

 ‘Caring for the world, one person at a time’... inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson (JnJ) Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
 
IPV is a department in Global Medical Safety (GMS), a group within the Global Medical Organization (GMO) of Janssen, a pharmaceutical company of JnJ. IPV seeks to improve the health of our local communities by translating global and local data into impactful insights to optimize patient and consumer product use, free from avoidable harm.
 
IPV is seeking to recruit a regional case management lead for EMEA, within IPV (International Pharmacovigilance (IPV). The regional IPV case management lead for EMEA has a reporting line into Global IPV case management Head.
 
The responsibilities of the regional case management lead for EMEA include but are not limited to the below;
 
 
ICSR MANAGEMENT AND RELATED ACTIVITIES
 
ICSR management
  • Ensure compliance with processes and systems for the collection, review, reporting, tracking and reconciliation of Adverse Events (AEs), AEs combined with product quality complaints (AE+PQCs) and special reporting situations obtained through all potential sources (e.g. spontaneous, clinical trials, data generation activities)
     
  • Accountable internally for ensuring that the EMEA IPV ICSR management teams meet procedurally defined timelines for management of safety information and any local regulatory agency defined timeline for submission of individual reports.
     
  • Accountable to the EMEA Area Medical Safety Team Leads in meeting regulatory requirements regarding case processing activities including information oversight and exchange with QPPV Office, GMS, International PV, Compliance Strategy and Analytics (CSA) and BQ as applicable, within the required timelines.
     
    Compliance monitoring
  • In cooperation with Compliance Strategic and Analytics (CSA), ensure performance of ICSR reconciliations and review compliance dashboards from CSA for accuracy.
     
    Business continuity
  • Ensure ICSR management business continuity in EMEA in order to safeguard compliance.
  • Ensure training compliance with GMO and local PV training requirements and other mandatory training as required by GMO, for ICSR management.
     
     
    PEOPLE MANAGEMENT & DEVELOPMENT
  • Adhering to the applicable HR processes, provide line-management support to direct reports (IPV area/country case managers or leads),
  • Establish a pro-active compliance culture and foster the highest standard of compliance and accountability in EMEA.
  • Focus on continuous operational excellence and process optimization capability building for the IPV case management personnel, to sustain an operational excellence focused mindset.
     
     
     
    PROCESSES & REGULATIONS
  • Write, review, update or validate local, regional or global ICSR management related procedural documents and ensure ICSR management related local implementation memo implementation.
     
  • Collaborate with area or medical safety team leads to understand changes in local regulations which may have an impact on ICSR management and support regional or global impact assessments.
     
  • Represent IPV ICSR management on regional or global projects to streamlines PV operations.
     
     
PHARMACOVIGILANCE SERVICE PROVISION
 
Inspection preparation & support
  • Ensure EMEA PV audit & inspection readiness related to IPV ICSR management, support of document requests prior to and during an audit or inspections, and address follow up actions from findings, as required.

Qualifications
EDUCATION & EXPERIENCE REQUIREMENTS
 
  • A degree in life or pharmaceutical sciences is preferred.
  • Expert knowledge in case management requirements in EMEA and sound knowledge of the corresponding regionally relevant ICSR related regulatory requirements.
  • Familiarity with global ICSR related global, regional and local PV procedural documents as applicable.
  • People leadership experience preferred.
  • Sound knowledge of global safety database (PRISM expertise is an added asset) and relevant IT safety systems.
  • Excellent verbal, written communication skills and fluency in the English language is required.
  • Project management capabilities would be a distinct advantage.
  • Ability to manage direct report is required,
     
  • By preference a minimum of 6 + years pharmaceutical industry experience with at least 3 years in a PV responsibility role.

Primary Location
United Kingdom-England-High Wycombe-
Organization
Janssen Cilag Ltd. (7360)
Job Function
Drug & Product Safety Operations
Requisition ID
1905725211W