Medical Safety Officer, Janssen Pharmaceutical R&D Job

Job description

Medical Safety Officer, Janssen Pharmaceutical R&D-2207151007DescriptionJanssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for a Medical Safety Officer to be located in Titusville, NJ or Horsham, PA or Raritan, NJ.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.comThriving 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 the evaluation of medical data and patient 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 support one or more of the following Therapeutic Areas (TAs): Immunology; Oncology; Neuroscience, Infectious Disease/Vaccines or Cardio/ Metabolism.
The MSO will report to and assist the Global Medical Safety (GMS) 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, 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 contribute to and supervise, when appropriate, the design and implementation of risk mitigation strategies to ensure the safe and appropriate use of Janssen products.
Principal Responsibilities: Provide 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; 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; 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 Leadership Team, and the Pharmaceuticals Medical Safety Council (MSC); Participate in HA interactions regarding safety and risk management, both written and verbal.
The MSO 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; Core Data Sheets (CDS); Informed Consent Form (ICF) 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; Participate on due diligence teams to evaluate Licensing & Acquisition opportunities.
QualificationsA Physician (MD or equivalent), is required. A Board Certification (if US) is preferred. A minimum of 6 years of experience in industry, academia or patient care settings is required. Direct experience in pharmacovigilance is strongly preferred. Strong skills in clinical medicine and assessment of medical data/safety information are required. Expertise 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. The 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 is required. Knowledge of pharmacovigilance regulatory requirements in US, the EU and globally is strongly preferred. Able to plan work to meet deadlines and effectively handle multiple priorities is required.
Strong interpersonal and administrative skills, excellent verbal and written communication skills, including formal presentation skills are required. Written skills as evidenced by publication and journal articles is also desirable. Fluent in written and spoken English.
Travel will be up to 10% both domestic and international.
BE VITAL in your career; be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W: LI NAJ2W:BioSpaceJ2W:BioTech_JCJ2W:AAPharmSJ2W:ASAJ2W:HireDiversity#JNJPhysiciansPrimary Location:North America-United States-New Jersey-RaritanOrganization: Janssen Research & Development, LLC. (6084)Job Function: Drug & Product Safety ScienceCertain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. EEO is the Law EEO is the Law GINA Supplement