AMERICAS Region Cross Sector Safety Head, International Pharmacovigilance
Location:
Hopewell Township , New Jersey
Posted:
April 02, 2017
Reference:
5595170109/1-en-us

Johnson & Johnson is hiring for an AMERICAS Region Cross Sector Safety Head, International Pharmacovigilance. The preferred location for this position is Titusville, New Jersey, however this person may be located at other Johnson & Johnson sites within New Jersey. The AMERICAS Region Cross Sector Safety Head, International Pharmacovigilance is the senior safety leader for Pharma and Consumer products for the AMERICAS Region, including NA and LATAM.


Caring for the world, one person at a time, has inspired and united the people of Johnson & Johnson for 125 years. 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. 


With $65 billion in 2011 sales, Johnson & Johnson is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices and diagnostics markets. The more than 250 Johnson & Johnson operating companies employ approximately 119,000 people in 60 countries throughout the world.


The AMERICAS Region Cross Sector 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 and OCMS in the region and ensure the GMO 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 Safety organization and build strong networks and collaborations with regional and local operating company leaders, and safety colleagues across all sectors in 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 serve as a member of the Medical Affairs Leadership Team in the AMERICAS region
  • Lead the realization of efficiency gains from the cross sector local safety model
 

Responsibilities include:


Oversee Pharma and Consumer product safety strategy, PV operational excellence and capability development in the AMERICAS, in partnership with LOCs, local safety officers (LSOs) and other business partners in the region. 


Align business partners in the region including the commercial organization, medical affairs, research & development and other business partners and LSOs to develop and implement strategies and action plans that meet all applicable PV obligations. Build strong networks and collaborations with safety colleagues from all sectors in the region.

 
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 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
  • Liaise with the other Regional Cross Sector Safety Heads in order to share best practices and knowledge

Raising the understanding of the strategic needs for PV in the region through:

  • Regular and ad hoc communication with key stakeholders in the area
  • Building knowledge platforms for PV in partnership with other regions

Contribute to global efforts to develop an LSO retention strategy including, career path and opportunities for recognition and participation in the global PV community.


Qualifications
  • BA in Technical, Business or Scientific Discipline is required.  Masters level or advanced degree in medicine, business, human relations is preferred.
  • A minimum of 10 years’ relevant experience in pharmaceutical, business development or other global regulated industry is required.
  • Experience with global Pharmacovigilance regulations is required.
  • Management experience and leading teams is required.
  • Experience working with senior stakeholders across functions is highly preferred
  • Up to 20% domestic and international travel is required for this position


Primary Location
United States-New Jersey-Titusville
Other Locations
North America-United States-New Jersey
Organization
Janssen Research & Development, LLC. (6084)
Job Function
Pharmacovigilance
Requisition ID
5595170109

A little about us:
Johnson & Johnson cares for the world - bringing innovative ideas, products and services to advance the health and well-being of people.

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