Janssen Pharmaceutical Research & Development, L.L.C., a
member of the Johnson & Johnson Family of Companies, is recruiting for a
Director, Safety Surveillance Physician Team Lead. This position will be based
in Horsham, PA (preferred), Titusville, NJ or, Raritan, NJ.
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 objective of this position is to
provide therapeutic area medical expertise in the evaluation of safety data
from a variety of sources as part of the overall Pharmacovigilance process;
this includes oversight of signal detection activities at the single case
level, single case medical review, vendor oversight, and management of
surveillance physicians. The Team Lead SSP will report to the Head of MSSI and
will ensure communication of potential single case medical review quality,
compliance and signal management issues when appropriate.
The Director Team Lead, Safety
Surveillance Physician (Director TL, SSP) has additional responsibilities to
those of the Director, SSP in that the TL will lead a group of physicians who
are responsible for single case signal detection and the medical evaluation of
adverse event data according to international regulation and company SOPs. The Director TL, SSP will be responsible for
assuring that the workload is appropriately assigned and that output meets
quality standards and will also be responsible for leading collaborative
interaction within the Global Medical Safety Operations (GMSO) and the Medical
Safety Assessment (MSA) Groups. The Director TL, SSP is expected to play a greater
role as a senior technical leader and when required, to provide guidance to
SSPs in evaluating safety issues/signals in collaboration with the Medical
Safety Officers. The medical expertise of the Director TL, SSP will be
reflected in activities such as managing product area or project team,
participating on cross-functional teams such as SOP committees, taskforces,
work streams etc. and representing GMS positions, processes and guidance to
external business partners.
supervise and provide leadership to the Safety Surveillance Physicians for JnJ
products under GMS responsibility.
Assign workflow as appropriate to assure compliance with timelines.
quality of output for single case signal detection activities preparation of
individual case safety reports (ICSRs) including Watch Lists, PSUR, PADER, and
product quality complaints.
Product Teams are set up as needed and oversee that the meetings meet the
standards of the MSSI group
active participation of SSP in Safety Management Teams (SMT)
therapeutic area/Pharmacovigilance issue guidance in the context of
Leading/managing a product team.
leadership in single case assessment and mentoring of new SSPs.
collaboration within GMS. The collaboration
must focus on ensuring that SSPs successfully leads GMS product teams,
participate in cross functional therapeutic area teams as medical subject
matter experts. The SSP must function as
a medical subject matter expert on safety issues/signal detection in the Safety
Management Teams, as well as leading the GMS Product Teams. Participate in
cross-functional activities, e.g. GMSO, MSA, IPV collaborations.
all aspects of medical evaluation of adverse event reports, including but not
limited to all serious and expedited reports.
medical and patient safety support to therapeutic team for pre- and
provide input and approve all SUSARS/AOSI prior to regulatory submission
in vendor oversight by ensuring that SSP conduct quality vendor review for
assigned products and escalate issues as appropriate. Provide training and knowledge transfer as
required and develop a working relationship aligned within the governance
projects and processes of technology and scientific innovations for the Medical
Safety Surveillance and Insight (MSSI) group.
Decision Making/Problem Solving:
- The primary
decision making responsibilities involve the evaluation of the group’s success
in meeting objectives of quality and timelines, and identifying potential
safety issues at an early stage to allow for the development of overall risk
- The Director TL,
SSP must have excellent interpersonal skills and supervise other physicians and
scientists with varying degrees of experience in the pharmaceutical industry.
- The Director TL, SSP must
have an understanding of international Pharmacovigilance regulations, GMS SOPs,
policies and procedures, and the SSP function selected tasks. These tasks could
be managerial or technical in nature.
- The Director TL, SSP will
function at a high level of independence and must be prepared to represent the
function and make decisions about the appropriate course of action to take when
confronted with specific issues and provide guidance to reporting SSPs.
Examples may include changes to the safety sections of investigator brochures,
developing plans for targeted monitoring of selected safety issues as part of
surveillance and/or Risk Management Plans and representing GMS on internal and
(MD or equivalent) with 5 or more years of substantial Pharmaceutical Industry
experience is required
Certified/Board Eligible/equivalent or minimum of 2 years post-graduate
training is desirable
skills in clinical medicine and pharmacovigilance, including experience in
post-marketing safety assessment is required
track record in dealing with difficult safety issues, clinical safety data, and
strong collaborative and networking skills is required
experience in supervising a group of employees preferred; proven leadership
to influence, negotiate and communicate with both internal and external customers.
to develop, implement, communicate and influence policy and strategy internally
and externally to the company
to work in a global team-oriented, matrix environment is desirable
to present complex data in a concise and understandable scientific manner
verbal and written communication skills
of Good Clinical Practices and PV regulatory requirements is required
in written and spoken English
knowledge of the use of Microsoft suite of software products including Excel
United States-Pennsylvania-HorshamOther Locations
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