Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for a Medical Safety Officer, Infectious Disease to be based out of any one of our office locations in Spring House, PA, 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 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.
- Reports to and assists the Global Medical Safety Therapeutic Area (TA) Safety Head in the safety assessment of assigned drugs within the Infections Disease TA that are marketed and/or in clinical development.
- Helps to ensure proactive and timely assessments of safety data to characterize the emerging and known safety profiles of the products within the TA
- Helps to 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
- Develops 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.
- 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). Participate in HA interactions regarding safety and risk management, both written and verbal.
- 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.
- 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
- A Physician (MD or equivalent), is required. A US Board certification preferred.
- A minimum of 6 years of experience in industry, academia or patient care settings is required
- Direct experience in pharmacovigilance is strongly preferred
- A minimum of 2 years in clinical practice after postgraduate training program is 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
- 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 is required.
- Knowledge of pharmacovigilance regulatory requirements in US, the EU and globally is strongly preferred
- Written skills as evidenced by publication and journal articles are also desirable.
- Travel will be up to 10%, both domestic and international required
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.
United States-New Jersey-Raritan-
North America-United States-Pennsylvania-Horsham, North America-United States-Pennsylvania-Spring House
Janssen Research & Development, LLC (6084)
Drug & Product Safety Science