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.
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
- 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
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
Ensure Inspection Readiness:
- Proactively lead preparations for PV audits (internal or partner) and
HA inspections. Facilitate the preparation and finalization of the response to
- 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
- Conduct and maintain ongoing PV risk assessment, with a robust strategy
- 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
United States-New Jersey-TitusvilleOther Locations
North America-United States-New JerseyOrganization
Janssen Research & Development, LLC. (6084)Job Function