Janssen Pharmaceutical, a member of Johnson & Johnson's Family of Companies, is recruiting for a Medical Safety Officer, Oncology. The position will be located in either Horsham, PA, Titusville, NJ or Raritan, NJ. Remote work options may be considered on a case-by-case basis and if approved by the Company.
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.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
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), Hematological Malignancies, and oversee the safety and benefit/risk assessment of assigned products within the Hematological Malignancy 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.
This role will be responsible for but not limited to the following :
- 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