Johnson & Johnson Careers

Cross Sector Regional Safety Head, International Pharmacovigilance, The Americas

Titusville, New Jersey; Spring House, Pennsylvania; San Diego, California; Toronto, Canada
Pharmacovigilance


Job Description

Requisition ID: 3152190822

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. 

The Americas Cross Sector Regional Safety Head, International Pharmacovigilance is the senior safety leader for Pharma and Consumer products for the Americas Region.

The Americas Cross Sector Regional Safety Head will:

  • Oversee Pharma and Consumer product safety strategy and pharmacovigilance (PV) operations in the region while maintaining highest level of compliance with local regulations and JNJ global policies.
  • Be the face of GMO/GMS/OCMS in the region and ensure the strategy is translated and deployed on a regional level.
  • Oversee development and implementation of local Risk Management Plans and proactively address any emerging safety concerns.  Ensure fulfillment of safety obligations adopted as part of marketing authorizations and other commitments relating to the safe use of the products, including risk minimization measures and post-authorization safety studies requested by a health authority (HA).
  • Lead the Americas Local Consumer Safety organization and build strong networks and collaborations with Pharma local safety colleagues across the region.
  • Engage in the review of Post Approval Safety Study protocols conducted locally.
  • Drive the Pharma and Consumer safety strategic and operational interests in the region and serve as a key interface between global functions, regional leadership and the local operating companies (LOCs). 
  • Ensure responsibilities outlined in the Service Level Agreements between Pharma and Consumer safety organizations and the LOCs are mutually fulfilled with respect to product safety accountabilities.  
  • Oversee Pharma and Consumer medical safety operational and local facing area leaders in the region.
Contribute to inspection readiness and training related to Pharma and Consumer safety policies and procedures. Participate in product safety issue management with local and regional leaders and support regional  Leadership Teams as appropriate.  

Ensure Inspection Readiness:

  • Proactively lead preparations for PV audits (internal or partner) and HA inspections. Facilitate the preparation and finalization of the response to audit/inspection observations
  • Coordinate all regional safety activities including policy and procedure development, implementing and facilitating compliance with Service Level Agreements. Oversight of Americas Consumer safety staff and infrastructure
  • Develop and implement comprehensive training and quality program, in collaboration with the regional and local leadership and Pharma and Consumer safety partners allowing the LSOs to be inspection ready
  • Collect, analyze and remediate performance metrics for the region, in collaboration with Pharma and Consumer medical safety, regional and local leadership
  • Conduct and maintain ongoing PV risk assessment, with a robust strategy for remediation. 


Qualifications

The successful candidate will have BA in Technical, Business or Scientific Discipline required. 

Masters level or advanced degree in medicine, business, human relations, 

A minimum of 9 years relevant experience in pharmaceutical, business development or other global regulated industry required in lieu of Masters degree.

International exposure in pharmacovigilance.
 
Pharmaceutical Company or other relevant industry experience in the areas of regulatory affairs, quality, pharmacovigilance, business development and related areas required.
Primary Location
United States-New Jersey-Titusville-1125 Trenton Harbourton Road
Other Locations
United States-Pennsylvania-Spring House, United States-California-San Diego, Canada-Ontario-Toronto
Organization
Janssen Research & Development, LLC (6084)
Job Function
Pharmacovigilance
Requisition ID
3152190822