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Medical Safety Officer, Immunology
Titusville, New Jersey; Raritan, New Jersey; Horsham, Pennsylvania
Drug & Product Safety Science
Requisition ID: 2476180201
Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for a Medical Safety Officer to be based out of either one of our office locations in Titusville, NJ, Horsham, PA, 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 employer.
The Pharmaceuticals 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 Janssen products and strategically leading cross-functional matrix teams responsible for product safety and benefit risk oversight.
The MSO will report to the Global Medical Safety (GMS) Therapeutic Area (TA) Safety Head and oversee the safety 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 their products within the TA. The MSO will communicate potential and known risks, when appropriate, to the TA Safety Head, Head of Medical Safety Assessment (MSA), 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.
- Strategically lead the Safety Management Teams (SMT) for assigned products. SMT 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 products
- Provide medical and scientific 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 impact by active participation in the design of the clinical protocols.
- 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 (SCS) for NDA/BLA/MAA filings
- Periodic Benefit Risk Evaluation Report (PBRER) Safety Update Report (PSUR)
- Health authority queries
- Core Data Sheets (CDS)
- 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)
- Actively participate and contribute to meetings with Health Authorities and external key opinion leaders
- Provide medical safety leadership on due diligence teams to evaluate Licensing & Acquisition opportunities
- Provide medical oversight to contractors and non-physician staff involved in preparing written safety evaluations for their assigned products. This will include:
- Defining the safety question or issue requiring medical safety assessment
- Developing 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) medical assessment reports, e.g. ad hoc safety reports
- Work 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
- Lead or actively participate in department-wide initiatives
- This is not an exhaustive, comprehensive listing of job functions. May perform other duties as assigned
- A Physician (MD or equivalent), is required. A Board Certification (if US) is preferred.
- A minimum of 6 years of related experience as defined by the following:
- A minimum of 2 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 (includes a residency program or equivalent)
- Direct experience in pharmacovigilance is strongly preferred
- Strong skills in clinical medicine and assessment of medical data/safety information are required
- Medical specialization is preferred
- Demonstrated knowledge in one or more of the following is strongly preferred; principles of drug development, pharmacology, clinical trial methodology and design, medical monitoring of trials, assessment of drug risks and benefits, safety assessment of drugs both on the market and in development and global safety regulations
- Previous submission experience is preferred
- Ability 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.
- 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
- Knowledge of pharmacovigilance regulatory requirements in US, the EU and globally is strongly preferred.
- Ability to influence, negotiate and communicate with both internal and external stakeholders
- Experience with Health Authority presentations is preferred.
- Ability to effectively and strategically lead global cross-functional teams
- Connect, collaborate and build consensus across relevant function
- 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 and potential strategic impact of the data and present the findings clearly in both written and oral communications.
- Excellent verbal and written communication skills, including formal presentation skills. Written skills as evidenced by publication and journal articles also desirable
- Travel will be up to 10%, both domestic and international.
United States-New Jersey-Titusville
North America-United States-Pennsylvania-Horsham, North America-United States-New Jersey-Raritan
Janssen Research & Development, LLC. (6084)
Drug & Product Safety Science