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 information.
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 assigned products/reports.
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.
- Have in-depth
product knowledge, serve as product point of contact, and will support
Safety Management Team deliverables.
- Partner with
team members, stakeholders including Medical Safety Officer (MSOs), and a
vendor. Function independently and will have expert knowledge of
applicable regulations and guidelines.
- Work closely
with Therapeutic Area Lead to support the therapeutic area business.
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
- Complete and
coordinate complex product reports.
commitments (e.g., PV Agreements, assessment reports) are met.
- Partner with
vendor to develop reports/deliverables.
- Work closely
with management to proactively support Therapeutic Area related business.
enhanced Safety Management Team (SMT) support to enable proactive safety
- Act as core
member for assigned products.
innovative solutions for aggregate safety strategy and analyses and ensure
high quality reports.
purpose of Training/Meetings/Audits/Inspections:
- Participate in
cross-functional training of relevant stakeholders.
- May act as
product or process Subject Matter Expert (SME) during audits/inspections.
- Participate or
lead department and/or cross-functional initiatives.
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.
- Have the
ability to understand nature of adverse drug reactions and complex
- Maintain 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.
- Ability to
work across multiple functions and therapeutic areas.
regulatory assessor comments/requests and accommodate/address as
position reports into the Pharmacovigilance Evaluation and Reporting Director,
Therapeutic Area Lead.
- A 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 required.
- A minimum of 3+ years of
Clinical/Medical writing or PV experience required.
- Fluent English verbal and
written communication skills are required.
- High proficiency in the
analysis of large and/or complex aggregate data sets is required.
- Ability to develop in-depth
knowledge of assigned products is required.
- Knowledge of applicable global,
regional, and local regulatory requirements (e.g., ICH guidelines) is
- Knowledge and experience in
more than one therapeutic area is preferred.
- Ability to effectively present
to cross-functional teams is required.
- Travel 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 Science