Janssen Research & Development, LLC, a Johnson & Johnson
Company, is currently recruiting for a Manager, Pharmacovigilance Evaluation
and Reporting (PVER) Scientist, to be located in Horsham, PA, Titusville, NJ,
Raritan, NJ, or High Wycombe, UK.
This is an individual contributor role, not a people manager role.
At the Janssen Pharmaceutical Companies of Johnson & Johnson,
what matters most is helping people live full and healthy lives. We focus on
treating, curing and preventing some of the most devastating and complex
diseases of our time. And we pursue the most promising science, wherever it
might be found.
Janssen Research & Development, LLC discovers and develops
innovative medical solutions to address important unmet medical needs in
oncology, immunology, neuroscience, infectious diseases and vaccines, and
cardiovascular and metabolic diseases. Please visit http://www.janssenrnd.com/ for more
We are Janssen. Our mission drives us. Our patients inspire us. We
collaborate with the world for the health of everyone in it.
The Manager, Pharmacovigilance Evaluation and Reporting
Scientist will be responsible for core safety deliverables including
scheduled and ad hoc aggregate reports and will serve as report owner for
Scheduled reports include; PBRERs/PSURs, PADERs, Addendums to
Clinical Overview, and PBRER/PSUR Addendum Reports. Non-scheduled reports
include Ad hoc reports in response to health authority queries or internal
requests, health hazard evaluations, and labelling support documents.
activities involve; leading strategy development, planning, conducting
meetings, database searching, aggregate safety analysis and case level
review, writing, project management/coordination of strategic safety
documents, and oversight of deliverables produced by other team members.
in-depth product knowledge, serve as product point of contact, and will
support Safety Management Team deliverables.
with team members, stakeholders including Medical Safety Officer (MSOs),
and a vendor. Function independently and will have expert knowledge of
applicable regulations and guidelines.
closely with Therapeutic Area Lead to support the therapeutic area
plan and ensure timely, quality reports/safety analyses related to core
collaboration with Therapeutic Area Safety Head (TASH)/MSO/Safety
Surveillance Physician (SSP) and other stakeholders on strategy
development and oversee execution.
perform and/or lead aggregate safety analysis and case level review and
write, contribute to, and coordinate the preparation of core safety
and coordinate complex product reports.
commitments (e.g., PV Agreements, assessment reports) are met.
with vendor to develop reports/deliverables.
closely with management to proactively support Therapeutic Area related
enhanced Safety Management Team (SMT) support to enable proactive safety
as core member for assigned products.
innovative solutions for aggregate safety strategy and analyses and ensure
high quality reports.
For the purpose of Training/Meetings/Audits/Inspections:
in cross-functional training of relevant stakeholders.
act as product or process Subject Matter Expert (SME) during
or lead department and/or cross-functional initiatives.
Decision-Making and Problem Solving:
strategically with respect to data interpretation and provide innovative
potential issues and or safety issues and escalate to the attention of the
line manager or MSO.
the ability to understand nature of adverse drug reactions and complex
a high level of flexibility, multi-tasking, and ability to (re)prioritize
work of oneself and others. Have attention to detail and ability to
analyze data in broader context.
to work across multiple functions and therapeutic areas.
regulatory assessor comments/requests and accommodate/address as
This position reports into the Pharmacovigilance Evaluation and
Reporting Director, Therapeutic Area Lead.
minimum of a Bachelor’s Degree in Health or Biomedical Science with 9+
years of industry experience or equivalent OR an Advanced Degree in Health
or Biomedical Science with 6+ years industry experience or equivalent is
minimum of 3+ years of Clinical/Medical writing OR PV experience required.
English verbal and written communication skills are required.
proficiency in the analysis of large and/or complex aggregate data sets is
to develop in-depth knowledge of assigned products is required.
of applicable global, regional, and local regulatory requirements (e.g.,
ICH guidelines) is required.
and experience in more than one therapeutic area is preferred.
to effectively present to cross-functional teams is required.
will be minimal.
United States-Pennsylvania-HorshamOther Locations
Europe/Middle East/Africa-United Kingdom-England-High Wycombe, North America-United States-New Jersey-Titusville, North America-United States-New Jersey-RaritanOrganization
Janssen Research & Development, LLC. (6084)Job Function
Drug & Product Safety ScienceRequisition ID