Medical Safety Officer (MSO) CVM and ID

  • Company:
    J&J Family of Companies
  • Location:
  • Salary:
    negotiable / month
  • Job type:
    Full-Time
  • Posted:
    9 hours ago
  • Category:
    General

Janssen Research & Development, L.L.C., a member of Johnson &
Johnson’s Family of Companies, is recruiting for a Pharmaceuticals Medical
Safety Officer (MSO) CVM and ID located in Titusville, NJ or globally within our Janssen
teams.

Janssen Research & Development, L.L.C. develops treatments that
improve the health and lifestyles of people worldwide. Research and development
areas encompass novel targets in neurologic disorders, gastroenterology,
oncology, infectious disease, diabetes, hematology, metabolic disorders,
immunologic disorders, and reproductive medicine.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we
are working to create a world without disease. Transforming lives by finding
new and better ways to prevent, intercept, treat and cure disease inspires us.
We bring together the best minds and pursue the most promising science. We are
Janssen. We collaborate with the world for the health of everyone in it. Learn
more at www.janssen.com and follow us @JanssenGlobal. Janssen
Research & Development, LLC is part of the Janssen Pharmaceutical
Companies.

The Pharmaceuticals Medical Safety Officer (MSO) has accountability for
assessing the medical safety of assigned Janssen products and will
strategically lead cross-functional matrix teams responsible for product safety
and benefit risk oversight and represents Global Medical Safety (GMS) as the
product spokesperson regarding overall benefit/risk.

The MSO will report to the GMS Therapeutic Area (TA) Safety Head and
oversee the safety and benefit/risk assessment of assigned drugs within the TA
that are marketed and/or in clinical development.

Collaborating with relevant functions, the MSO will ensure proactive
and timely assessments of safety data to characterize the emerging and known
safety profiles and benefit risk of assigned products within the TA. The MSO
will communicate potential and known risks and changes to benefit/risk, when
appropriate, to the TA Safety Head, the Medical Safety Science and Risk
Management Excellence Leader, Head of Medical Safety Strategy (MSS), the Chief
Safety Officer (CSO), the Pharmaceuticals Chief Medical Officer (CMO), the
Qualified Person for Pharmacovigilance (QPPV) Pharma, Senior Management, Health
Authorities (HA), Prescribers and/or Patients.

In compliance with legal and regulatory requirements, the MSO will also
lead when appropriate, in the design and implementation of risk mitigation
strategies to ensure the safe and appropriate use of Janssen products.

Principal Responsibilities:

+ Strategically lead
the Safety Management Teams (SMT) for assigned products. SMT responsibilities
include safety surveillance (including signal detection), benefit/risk
assessment 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 products.

+ Provide medical and
safety expertise as the GMS representative on the Compound Development Team
(CDT) and Clinical Teams

+ Anticipate safety
concerns and influence other relevant functions including Clinical teams to
minimize/mitigate patient risks by active participation in the design of the
clinical protocols.

+ Contribute to
structured benefit-risk assessment in development and post-approval in collaboration
with the Benefit-Risk Team and Clinical teams.

+ Effectively
communicate (verbally and in writing) important results of medical safety and
benefit/risk management evaluations when necessary, to the GMS Leadership Team,
CMO, and the Pharmaceuticals Medical Safety Council (MSC)

+ This is not an exhaustive, comprehensive listing of job functions. May perform other duties as assigned.

+ Be an active
partner and core contributor of safety input to key regulatory or clinical
documents including:

+ Risk management
plans

+ Safety development
plan

+ Clinical Trial
Protocols

+ Informed Consent
Forms (ICF)

+ 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

+ Periodic Benefit
Risk Evaluation Report (PBRER) Safety Update Report (PSUR)

+ Health authority
queries

+ Core Data Sheets
(CDS)

Qualifications

+ Physician (MD or equivalent) with 6 or more years of related experience as defined by the following:

+ Requires at least 2 or more years of pharmacovigilance experience or other relevant experience (e.g. Clinical research in Pharma or academic setting, Medical Affairs)

+ Demonstrated skills in clinical medicine with at least 4 years of clinical practice experience, which includes a residency program or equivalent) preferred

+ Demonstrated knowledge of principles of drug development, pharmacology, clinical trial methodology and design, medical monitoring of trials, assessment of drug risks and benefits, and safety assessment of drugs both on the market and in development and global safety regulations highly preferred

+ Experience with structured benefit-risk frameworks (e.g. BRAT, FDA) and current regulatory policy on benefit-risk assessment and patient-focused drug development is preferred

Required Technical Knowledge and Skills:

+ Ability to
effectively and strategically lead global cross-functional teams

+ Ability to think
strategically, has a global mindset, big picture orientation, Ability to see
the context of the entire situation, understand implications to the business

+ Ability to
critically evaluate safety data from multiple sources (clinical trials,
environment, literature, etc), assess clinical importance, benefit risk and
potential strategic impact of the data and present the findings clearly in both
written and oral communications.

+ Experience and
knowledge of Good Clinical Practices and Pharmacovigilance regulatory
requirements in US, the EU and globally, the conduct of clinical trials and for
the appropriate contributions to regulatory filings, PV documents and risk
management plans

+ Able to plan work
to meet deadlines and effectively handle multiple priorities

Johnson & Johnson is an Affirmative Action and Equal Opportunity
Employer. All qualified applicants will receive consideration for employment
without regard to race, color, religion, sex, sexual orientation, gender
identity, age, national origin, or protected veteran status and will not be
discriminated against on the basis of disability.

Primary Location

United States-New Jersey-Titusville-

Other Locations

United Kingdom-England-High Wycombe, United States-New Jersey-Cherry Hill, United States-New Jersey-Raritan, United States-Pennsylvania-Horsham, Belgium-Antwerp-Beerse

Organization

Janssen Research & Development, LLC (6084)

Job Function

R&D

Requisition ID

9156200728





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