Janssen Research & Development, LLC, a Johnson & Johnson
Company, is currently recruiting for an Associate Director, Pharmacovigilance
Evaluation and Reporting (PVER) Scientist, to be located in Horsham, PA,
Titusville, NJ, High Wycombe, UK, or Raritan, NJ.
This is an individual contributor role, not a people manager
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 Associate Director, 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.
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; lead strategy development for assigned reports, plan
and conduct meetings, perform database searching, aggregate safety
analysis and case level review, write assigned reports, manage complex
projects and coordinate strategic safety documents, provide oversight of
deliverables produced by other team members.
in-depth product knowledge, serve as product point of contact, and support
Safety Management Team deliverables.
with team members, stakeholders including Medical Safety Officer (MSOs),
and a vendor. Function independently and have expert knowledge of
applicable regulations and guidelines.
plan and ensure timely, quality reports/safety analyses related to core
with Therapeutic Area Safety Head (TASH)/MSO/Safety Surveillance Physician
(SSP) and other stakeholders on strategy development for aggregate safety
perform and/or lead aggregate safety analysis and case level review and
write, contribute to, and coordinate the preparation of core safety
complex product reports where coordination and leadership of multiple
scientists are required.
commitments (e.g., PV Agreements, assessment reports) are met.
with vendor to develop reports/deliverables.
closely with management to proactively support Therapeutic Area related
serve as Therapeutic Area Lead back up.
enhanced Safety Management Team (SMT) support to enable proactive safety
management and act as core member of the SMT 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.
as product or process Subject Matter Expert (SME) or departmental
representative during audits/inspections.
training needs and develop/execute training plan for department.
department and/or cross-functional initiatives.
closely with team members to ensure a consistent approach to deliverables
in the assigned therapeutic area and across department.
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.
- A minimum of a Bachelor’s Degree in Health or Biomedical
Science with 13+ years of industry experience or equivalent OR an Advanced
Degree in Health or Biomedical Science with 9+ years industry experience
or equivalent is required.
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 Oncology is preferred.
to effectively present to cross-functional teams is required.
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