Pharmaceuticals Medical Safety Officer

工作内容

Working with Johnson & Johnson can change everything. Including YOU. 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 Safety Head (TASH), and oversee the safety and benefit/risk assessment of assigned products within the Therapeutic Area (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 assessment 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 Head of Global Safety Strategy & Risk Management (GSSRM), 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. Qualifications Your key responsibilities: 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 (e.g., Program Safety Analysis Plan) 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 and Medical Affairs 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 Clinical Trial, EAP and IIS Protocols Informed Consent Forms (ICF), including Risk Language Safety Sections of Investigator’s Brochure (IB) and IB addenda Safety sections of Clinical Study Reports (CSR) 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), Development Safety Update Report (DSUR) Health authority queries Company Core Data Sheets (CCDS), US and EU prescribing information Signal Evaluations 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 The MSO takes a leadership role in influencing senior management and key stakeholders across the business to achieve strategic goals. Leads others by example in influencing internal and external partners; demonstrates openness and seeks to understand different perspectives; gains the trust of others; asserts personal ideas and opinions using persuasion to influence others; demonstrates excellent negotiation skills. Gathers diverse viewpoints; proactively influences others appropriately across departments, functional areas, and with external partners. The MSO is viewed as a trusted partner across the business and with internal and external therapeutic area experts; anticipates additional needed relationships and proactively takes actions; leverages relationships; develops strategic alliances and coalitions. Uses an active network of relationships to achieve goals; fosters teamwork within own department or function, as well as across departments or functions; proactively addresses organizational barriers to enhance team effectiveness; leads the development of productive relationships among senior leaders and across organizational boundaries. Proactively maintains relationships with internal and external business partners across departments and functions; contributes actively to the effectiveness of cross-functional teams; capitalizes on existing structures and procedures for effectively engaging with partners. Required Education and Experience: Physician (MD or equivalent), generally requires 2-5 years of pharmacovigilance experience or other relevant experience (e.g. Clinical research, Medical Affairs) Board Certification (if US) preferred Medical specialization preferred Demonstrated skills in clinical medicine with at least 1 year of clinical practice experience 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 Ability to influence, negotiate and communicate with both internal and external stakeholders Experience with Health Authority presentations is preferred. Required Technical Knowledge and Skills: Ability to effectively and strategically lead global cross-functional teams Connect, collaborate and build consensus across relevant functions 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. 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 Excellent verbal and written communication skills, including formal presentation skills. Written skills as evidenced by publication and journal articles also desirable Fluent in written and spoken English Proficiency in Word and PowerPoint is desired Are you ready to make an impact? If you want to leave your personal mark and be valued for who you are, Johnson & Johnson offers an unusual experience to professionals looking for an opportunity to work with hardworking people who share your real passion for caring in an environment that empowers you to drive your own career and that you feel you can bring your whole self to work. We provide you an environment to fulfil your career aspirations as well as promoting your physical and mental wellbeing. You will receive a competitive compensation and benefits package as well as benefits that can be tailored to what is valuable to you throughout different stages of your life. About Janssen, the Pharmaceutical Companies of Johnson & Johnson At Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension. We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. Ready to be part of something great? Don’t forget to apply. We want YOU! Primary Location Belgium-Antwerp-Beerse- Other Locations Europe/Middle East/Africa-Netherlands-South Holland-Leiden Organization Janssen Pharmaceutica N.V. (7555) Job Function R&D Requisition ID 2105980999W