Medical Safety Officer Vaccines
Johnson & Johnson
Beerse, Belgium
6 dagen geleden

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 :

  • Risk management plans
  • Safety development plan
  • Clinical Trial Protocols
  • Informed Consent Forms (ICF)
  • 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 Benefit Risk Evaluation Report (PBRER) Safety Update Report (PSUR)
  • Health authority queries
  • Core Data Sheets (CDS)
  • 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

    Qualifications

    Education and Experience :

  • Physician (MD or equivalent) with 6-9 years related experience as defined by the following :
  • Requires at least 2-5 years of pharmacovigilance experience or other relevant experience (e.g. Clinical research in Pharma or academic setting, Medical Affairs)
  • Demonstrated skills in clinical medicine with at least 4 years of clinical practice experience, which includes a residency program or equivalent)
  • Board Certification (if US) preferred
  • Medical specialization preferred
  • 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
  • Demonstrated knowledge of biostatistics and epidemiology are preferred
  • Experience with structured benefit-risk frameworks (e.g. BRAT, FDA) and current regulatory policy on benefit-risk assessment and patient-focused drug development is preferred
  • Ability to influence, negotiate and communicate with both internal and external stakeholders
  • Experience with Health Authority presentations is preferred.
  • Required Technical Knowledge and Soft Skills :

  • Ability to effectively and strategically lead global cross-functional teams
  • Connect, collaborate and build consensus across relevant function
  • 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, benefit risk 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
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