Medical Safety Officer (MSO) CVM and ID - Janssen Pharmaceuticals - Beerse

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)
  

• 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.