Janssen Research & Development, L.L.C., a division of Johnson
& Johnson's Family of Companies is recruiting for a Medical Safety Officer
Infectious Disease to be based out of 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.
Thriving on a diverse company culture, celebrating the uniqueness
of our employees and committed to inclusion. Proud to be an equal opportunity
The Medical Safety Officer (MSO) is a physician with training or
experience in Medical Safety, who reports into the Medical Safety organization and
has accountability for assessing the Medical Safety of products or product
families and the reasonable mitigation of risk associated with such
to and assists the Global Medical Safety Therapeutic Area (TA) Safety Head
in the safety assessment of assigned drugs within the Infectious Disease TA that are marketed and/or
in clinical development.
to ensure proactive and timely assessments of safety data to characterize
the emerging and known safety profiles of the products within the TA
to ensure communication of potential and known risks, when appropriate, to
the TA Safety Head, Head of Medical Safety Assessment (MSA), the
Pharmaceuticals Chief Medical Officer (CMO), the Qualified Person for
Pharmacovigilance (QPPV) Pharma, Senior Management, Health Authorities
(HA), Prescribers and/or Patients.
compliance with legal and regulatory requirements, the MSO will also
contribute to and supervise, when appropriate, the design and
implementation of risk mitigation strategies to ensure the safe and
appropriate use of Janssen Research & Development, LLC products.
Medical Safety Officer provides medical expertise to the GMS TA and
provide medical oversight to non-physician GMS staff including defining
the safety question or issue requiring medical safety assessment
the strategy for the safety review and analysis, interpreting results and
determining the medical importance of question or issue, reviewing and
approving (i.e., signatory) for medical assessment reports, e.g. ad hoc
safety reports, and providing end-to-end (Phase 1 through product life
cycle) safety support and surveillance.
The MSO will chair a multidisciplinary Safety Management Teams
(SMT) for assigned products whose responsibilities include safety surveillance
(including signal detection) and risk management activities (including Risk
Management Plan (RMP) and Risk Evaluation and Mitigation Strategy (REMS)), as
well as other activities related to managing the safety profile of assigned
on TA Clinical Development Teams (CDTs) and Clinical Teams (CTs) as deemed
necessary by the TA Safety Head, present medical safety and risk
management evaluations as necessary to the CMO, the GMS Senior Leadership
Team, and the Pharmaceuticals Medical Safety Council (MSC). Participate in
HA interactions regarding safety and risk management, both written and
input and review to key regulatory or clinical documents as appropriate to
ensure these key safety documents are of high medical and scientific
quality. These might include: Clinical Trial Protocols, Safety Sections of
Investigator’s Brochure (IB) and IB addenda, Clinical Study Reports (CSR),
Annual Safety Reports (ASR), Integrated Safety Summary (ISS) and Summary
of Clinical Safety (SCS) for NDA/BLA/MAA filings,
Periodic Safety Update Report (PSUR), Core Data Sheets (CDS), and Informed
Consent Form Risk Template.
across the GMS TAs to align and improve common processes including
providing strong leadership and a harmonized approach across clinical
teams for safety data collection, assessment, and safety-related processes
and issues, assist in the creation, review and implementation of new SOPs,
Work Instructions, guidelines, documents and other tools pertaining to
safety assessment and risk management.
on due diligence teams to evaluate Licensing & Acquisition opportunities
Physician (MD or equivalent), is required. A Board Certification (if US)
- A minimum of 6 years of experience in industry, academia or
patient care settings is required.
- Direct experience in pharmacovigilance is strongly preferred
- A minimum of 2 years in clinical practice after postgraduate
training program is preferred.
- Strong skills in clinical medicine and assessment of medical
data/safety information are required.
in one or more of the following is strongly preferred; drug development,
pharmacology, clinical trial methodology and design, medical affairs,
assessment of drug risks and benefits (both on the market and in
development) and global safety regulations.
submission experience is preferred
to critically evaluate safety data from multiple sources (clinical trials,
environment, literature, etc.), assess clinical importance and potential
strategic impact of the data and present the findings clearly in both
written and oral communications is required.
and knowledge of Good Clinical Practices is required.
of pharmacovigilance regulatory requirements in US, the EU and globally is
skills as evidenced by publication and journal articles are also
will be up to 10%, both domestic and international.
United States-New Jersey-TitusvilleOther Locations
North America-United States-New Jersey-RaritanOrganization
Janssen Research & Development, LLC. (6084)Job Function