Johnson & Johnson Careers

Country Medical Safety Team Lead UK/Ireland

High Wycombe, United Kingdom
Drug & Product Safety Operations


Job Description

Requisition ID: 1905735588W

At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases, and vaccines, cardiovascular and metabolic diseases.  Driven by our commitment to patients, we bring innovative products, services and solutions to people throughout the world. Janssen is a pharmaceutical company of Johnson& Johnson (J&J).  Please visit http://www.janssen.co.uk/ for more information.
 
POSITION SUMMARY:
The Country Medical Safety Team Lead UK/Ireland has the overall LSU responsibilities for the specific market according to the SLA between GMS and Jansen Pharma Company / J&J Consumer Company and OCMS and is the primary point of contact for the LOCs, for IPV and Global Medical Safety
 
 
OVERALL PURPOSE OF JOB
 
  • Serve as a Member of the International Pharmacovigilance (PV) Regional team
  • Provide Line-Management to the Local Medical Safety Teams by adhering to the applicable HR processes (eg five conversations) and ensure a harmonized approach is applied for all Global Medical Safety (GMS) employees.
  • Provide local management support to the Local Case Management team
  • Be an ambassador of the Office of the Chief Medical Officer (OCMO) culture and vision
  • Ensure the proper implementationof sector, global, regional and local processes and procedures
  • Drive and continuously improve compliance for products in the pharmaceutical and consumer product portfolios by proactively identifying compliance risk areas and managing the investigation of root causes contributing to the compliance issue, and development and accurate/timely implementation of corrective and preventative action plans
  • Participate, contribute and where appropriate lead local, regional and global project
  • Ensure best practices and lessons learned are shared at local, region and global Level
  • Collaborate with Compliance groups and Local Safety Unit (LSU= Local Medical Safety Team and Local Case Management team) to ensure accurate oversight information is provided to senior stakeholdersand regional and local Qualified Person Pharmacovigilance (QPPV)
  • Ensure appropriate support to the local Marketing Authorization Holder (MAH) to enable fulfilment of its regulatory responsibilities (including Pharmacovigilance Agreement (PVA’s)) and meet their business objectives
  • Build and establish local Medical Safety Capabilities, in co-cooperation with the International Medical Safety Leader (Pharma) and CSO/Regional MSO’s (Consumer) ensuring a consistent Medical and Scientific approach of the J&J Product Portfolio.
  •  Establish Product knowledge with focus on safety profiles, Therapeutic Area and Disease Pathway knowledge within the Local Medical Safety team in collaboration with the International Medical Safety Lead
  •  Ensure appropriate PV review of the local activities generating patient data across EMEA (including clinical research, other medical affairs activities, Market Research, ...)
  • Local, Pro-active Risk Management throughout the entire product life cycle taking into account local specificities and needs, based on global data
  • Focused engagement in local industry associations and drive local policy shaping initiatives based on One J&J Voice
  •  Ensure adequate support to LOCs for Inspection readiness through audit/inspection support, Corrective and Preventative Action Plans monitoring
  • Support Local Medical Safety team in negotiating and influencing local regulatory partnersto ensure alignment with global requirements and compliance with Health Care Business Integrity (HCBI)
  • Engage with key stakeholders in local operating company for both consumer and pharma
     
    PRINCIPAL RESPONSIBILITIES;
     
    People leadership & stakeholder management:
  • Act as GMS Single Point of Contact and provide advice and feedback to the local Medical Director in Consumer and Pharma sectors in support of PV responsibilities
  • Provide line-management to the Local Medical Safety teams, by adhering to the applicable HR processes
  • Support alignment and inclusion of Local Case Management team and IPV affairs representatives within LSU
  • Coach Local Medical Safety team in the implementation of regional and area business unit’s strategies
  • Establish a pro-active compliance culture and engage in Global Medical Organization (GMO) / Global Medical Safety (GMS) departmental activities
     
    Technical:
  • Collaborate with compliance groups and LSU employees to ensure accurate oversight information is provided to senior stakeholders and QPPV
  • Ensure adequate support to LSU for inspection readiness through audit/inspection support, corrective and preventative action plans monitoring
  • Sponsor, lead or support PV related local, regional or global projects
  • Collaborate with relevant individuals to facilitate compliance
  • Support implementation of PV systems
  • Contribute to the development of appropriate metrics
  • Ensure appropriate PV language for third party or inter-company related PV agreements
  • Remain up-to-date with new IT developments in pharmacovigilance, and provide advice on PV IT requirements
  • Ensure appropriate dissemination of PV regulations and guidelines to LSU team members and to the Office of the QPPV
  • Ensure appropriate PV review of company activities generating patient data across EMEA (including clinical research, other medical affairs activities, Market Research...)
  • Present the voice of the LSU and LOC to IPV Regional team 
  • Collect compliance data from LOC for dashboards and provide advice to LSU on handling
  • Ensure with the EMEA IPV LT and finance colleagues oversight on a cross-sector robust local IPV budget and HC management process

Qualifications
EDUCATION & EXPERIENCE REQUIREMENTS
 
  • Degree qualified ideally in life sciences
  • Qualification in Medical/ Health Sciences and/or proven equivalent experience in pharmacovigilance and safety issue management
  • Expertise in safety regulations and R&D processes
  • Experience of leading a PV Team and performing the role of an LSO
  • Minimum of 4 years’ experience in the pharmaceutical industry, with at least 2 years’ experience in a position of responsibility within Pharmacovigilance
  • Team leadership and people management experience are required
  • Flexibility and experience in developing, leading and playing a role within virtual teams
  • Fluent communication skills in English, any additional language is a plus.
     
ESSENTIAL KNOWLEDGE & SKILLS:
 
• Knowledge in Medical/Health Sciences required
• Knowledge of local/global legal requirements
• Knowledge about local business models and local legal requirements
• Comprehensive knowledge of global, EMEA and local Standard Operating Procedures (SOPs), and GMS database systems
• Demonstrable insight to the implementation PV regulatory requirements for medicinals, devices and cosmetics with knowledge of Global aspects of drug safety, including International AE reporting requirements and relevant country- specific variations
 
Product Development
• Familiarity of general industry principles of drug development
 
Strategy
• Good knowledge about all aspects of the business and strategic company goals
 
Processes & Systems
• IT literate with knowledge of PV systems within J&J companies (single case handling, and Periodic Safety Update Reporting (PSUR))
• High level MS Office PowerPoint, Excel and WORD skills
Understanding of Global Company policies in relation to Third Party agreements and communication
systems
 
Leadership & People Management
• Proven leadership and management capability with the ability to simplify complex workflows and
simultaneously manage critical issues in a complex and changing internal and external environment
• Excellent people management, negotiation skills and leadership in coaching people in influencing internal and external partners
• The ability to operate autonomously without direct supervision
• Demonstrated initiative and results orientation
• Analytical, and process minded with a systematic and orderly approach

Primary Location
United Kingdom-England-High Wycombe-
Organization
Janssen Cilag Ltd. (7360)
Job Function
Drug & Product Safety Operations
Requisition ID
1905735588W