Johnson & Johnson Careers

IPV AFFAIRS ASSOCIATE DIRECTOR

Titusville, New Jersey; Canada
Pharmacovigilance


Job Description

Requisition ID: 00001EJ8

Janssen Research & Development, LLC, a member of the Johnson & Johnson Family of Companies, is recruiting for an IPV Affairs Associate Director. The position can be located in in US (Raritan, Titusville, NJ or Malvern, Spring House, PA), and/or in Canada or Latin America Janssen locations. 


The The IPV Affairs Ass. Director will support the Global IPV Team in all strategic realizations and compliance operations related to the vigilance of the J&J product portfolio under the umbrella of International Pharmacovigilance (IPV)


The IPV Affairs Ass Director will ensure a consistent compliance and operations approach across the regions in alignment with the Global Medical Safety (GMS) and Global Medical Organization (GMO) processes


The IPV Affairs Associate Director will:
  • Oversee the IPV Project Management of Process Improvement Projects
  • Lead or participate in global or regional multi-disciplinary projects and shape strategies for the projects assigned. In partnership with the Regional Heads, the incumbent will enable improvement of compliance, consistency and overall inspection readiness across IPV 
  • Management and oversight of IPV key communication tools like IPV Monthly Reports, IPV and LSO Community SharePoint site, and IPV newsletter
  • Oversee global IPV Tracking systems (e.g. Targeted Follow-up Questionnaires, RMP, Due Diligence tracking, Reconciliation tracking), drive improvements  and increase efficiencies
  • Lead global implementation projects for new Procedures and Systems for IPV and coordinate IPV impact assessments to meet global standards and local applicable laws and needs. Function as direct contact point for GMS/ OCMS Operations
  • Support IPV in building and maintaining inspection readiness for all IPV related activities
  • Take ownership for global IPV processes in cooperation with relevant SMEs and stakeholders
  • Develop a globally consistent approach for assessing, recording and reporting of countries compliance status in close cooperation with CSA international. Escalate alert signals of non-compliance. Focus on risk identification and support mitigation as needed.Initiate and lead continuous improvement initiatives based on quality and compliance Key Performance Indicators
  • Contributing to the development of an standardized and integrated IPV quality system
  • Closely collaborate with CSA international to develop a Corrective and Preventive Action (CAPA) monitoring system and monitoring and follow-up on CAPAs, escalating non-adherence
  • Lead targeted IPV projects based on prioritization by the IPVLT to measurably improve global PV compliance and efficiencies in operations. Identify trends across regions and highlight opportunities to IPV Leadership team
  • Coordinate and own global IPV CAPAs as applicable
  • Ensure oversight and coordinate LSO assignments to regional and global projects (SMEs)
  • Develop strategy for composition and maintenance of IPV Curricula in close cooperation with CSA International
  • Coordinate roll-out of new/revised role profiles and competency model
  • Oversee global strategy for onboarding programs and support regions to develop strategy for LSO onboarding programs
  • Develop strategy and coordinate global training for IPV team and employees of the Local Safety Units depending on current needs (e.g. Global LSO Trainings, Lessons of the month) 


Qualifications
Qualifications
  • College/University degree in Medical, pharmaceutical or nature science degree with proven expertise and experience in pharmaceutical industry and experience in Pharmacovigilance required
  • Minimum of 8 years’ experience in a position of responsibility within Pharmacovigilance required
  • 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 required
  • Task-oriented with proven experience in the delivery of high-quality work and able to operate autonomously without direct supervision and as part of a multi-disciplinary team
  • In-depth understanding of vigilance systems and processes; knowledge of or experience with International Pharmacovigilance and compliance regulations and guidelines preferred
  • Demonstrable insight to the development of regulatory requirements with knowledge of
  • Global aspects of drugs or cosmetics or devices safety, including International reporting
  • requirements and relevant country-specific variations required
  • Proven Project Management experience including stakeholder management and change management
  • Experience required
  • Excellent computer-based application skills required
  • Fluent communication skills in English, any additional language is a plus
  • Up to 25% travel may be required
 Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
 


Primary Location
United States-New Jersey-Titusville-1125 Trenton Harbourton Road
Other Locations
North America-Canada, Latin America
Organization
Janssen Research & Development, LLC. (6084)
Job Function
Pharmacovigilance
Requisition ID
00001EJ8