Medical Safety Officer, Established Products

The Pharmaceuticals Medical Safety Officer (MSO) is a physician with training or experience in medical safety, who reports into the Global 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 lead the safety assessment of assigned marketed drugs within the Established Products Therapeutic Area (EP TA). 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 Head of Global Safety Strategy and 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 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 aggregate safety reports, risk management plans, safety reviews and analyses
• 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

• Provide end-to-end safety support and surveillance, including active participation in delisting or divesting activities
• Chair 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
• Effectively communicate 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, review, and approval of key safety, 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
• Informed Consent Form Risk Template
• Risk Management Plans
• 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

• 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
• Provide support to other active products within the TA as needed

• 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.
• 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; and proactively addresses organizational
barriers to enhance team effectiveness.