Medical Safety Officer - Immunology-1414141205
Description
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 any one of our office locations in Raritan, NJ, Titusville, NJ, Horsham, PA, or Spring House, PA.
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.
Janssen Pharmaceuticals, Inc., a pharmaceutical company of Johnson & Johnson, provides medicines for an array of health concerns in several therapeutic areas, including: attention deficit hyperactivity disorder (ADHD), cardiovascular disease, general medicine (acid reflux disease, infectious diseases), mental health (bipolar I disorder, schizophrenia), neurologics (Alzheimer’s disease, epilepsy, migraine prevention and treatment), pain management, and women’s health. Our ultimate goal is to help people live healthy lives. We have produced and marketed many first-in-class prescription medications and are poised to serve the broad needs of the healthcare market – from patients to practitioners, from clinics to hospitals. For more about Janssen Pharmaceuticals, Inc., one of the Pharmaceutical Companies of Johnson & Johnson, visit www.janssenpharmaceuticalsinc.com
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
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 products. The MSO will report to and assist the Global Medical Safety Therapeutic Area (TA) Safety Head in the safety assessment of assigned drugs within the TA that are marketed and/or in clinical development. The MSO will help ensure proactive and timely assessments of safety data to characterize the emerging and known safety profiles of the products within the TA. The MSO will help 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. In 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.
The 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, 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) 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 products. S/he will participate 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), and participate in HA interactions regarding safety and risk management, both written and verbal. S/he will provide 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. The MSO will 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, and participate on due diligence teams to evaluate Licensing & Acquisition opportunities.
Qualifications
A physician (MD or equivalent) with eight + years biopharmaceutical experience is required. Board Certification preferred.
Demonstrated skills in clinical medicine and Pharmacovigilance is required.
Ability to assess drug risks and benefits, and safety assessment of both marketed drugs and drugs in development is required.
Ability to influence, negotiate and communicate with both internal and external customers is required.
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 is required.
Ability to plan work to meet deadlines and effectively handle multiple priorities is required.
Excellent verbal and written communication skills, including formal presentation skills is required.
Demonstrated basic knowledge of principles of drug development, pharmacology, clinical trial methodology and design, and medical monitoring of trials is preferred.
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J2W: LI NA
J2W: BIO
Primary Location:North America-United States-Pennsylvania-Spring House
Organization: Janssen Research & Development, LLC. (6084)
Job Function: Drug & Product Safety Science
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