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Johnson & Johnson Karrieren

Country Safety Director (m/f/d)

Nordrhein-Westfalen, Deutschland
Drug & Product Safety Operations


Arbeitsplatzbeschreibung

Requisition ID: 1905741392W

‘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 Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.

 

Janssen Pharmaceutical joined the Johnson & Johnson Family of Companies in 1961. Today, Janssen Pharmaceutical is one of the most innovative pharmaceutical companies in the world. Our research and development centre develops products for a wide range of disease areas, such as mental disorders, neurological problems, infectious diseases, immunological disorders, cancer, and cardiovascular and metabolic conditions.

 

We are currently looking for an 


Country Safety Director (m/f/d)


The Country Medical Safety Team Lead Germany 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
  • Serves as Local Safety Officer ultimate responsible for the local PV related activities
  • 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 implementation of 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 stakeholders and 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 partners to 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

Act as local nominated person or deputy of the local nominated person (=Graduated Plan Officer) for Janssen-Cilag GmbH, Germany and for Johnson & Johnson GmbH, Germany.


The principal responsibilities and duties include:


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

Qualifikationen
  • 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 and German

ESSENTIAL KNOWLEDGE & SKILLS:

General knowledge on healthcare and safety

• 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

The well-being and development of our employees are central aspects of our company creed. Individuals who would like to fully realize their potential as part of our international, innovation-driven corporate family and who aspire to have challenging work, will find that our company provides just the right conditions. We consider intensive initial training, further education that is tailored to our employees' work and excellent opportunities for development - both nationally and internationally - to be just as essential as a good work-life balance, attractive compensation and above-average employee benefits. One aspect that distinguishes our company is the large number of measures we have to support our trainees and promote career development in ways that are also compatible with family life.


Primärer Standort
Deutschland-Nordrhein-Westfalen--
Organisation
Janssen-Cilag Germany (8000)
Funktion
Drug & Product Safety Operations
Requisition ID
1905741392W