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 (TA) Safety Head and oversee the safety and benefit / risk assessment of assigned drugs within the 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 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 Medical Safety Science and Risk Management Excellence Leader, Head of Medical Safety Strategy (MSS), 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.
PRINCIPAL RESPONSIBILITIES :
Strategically lead the Safety Management Teams (SMT) for assigned products. SMT responsibilities include safety surveillance (including signal detection), benefit / risk assessment 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
Provide medical and safety expertise as the GMS representative on the Compound Development Team (CDT) and Clinical Teams
Anticipate safety concerns and influence other relevant functions including Clinical teams to minimize / mitigate patient risks 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 :
Contribute to structured benefit-risk assessment in development and post-approval in collaboration with the Benefit-Risk Team and Clinical teams.
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)
Provide medical oversight for safety data evaluations by confirming the strategy for the safety review / analysis and endorsing the medical safety evaluation.
This will include review and approval (i.e. signatory) of medical safety assessment reports and other aggregate safety reports.
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
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 SOPs, Work Instructions, guidelines, documents and other tools pertaining to safety assessment and risk management
Lead or actively participate in department-wide initiatives
Education and Experience :
Required Technical Knowledge and Soft Skills :