Medical Safety Officer, Established Products

Johnson & Johnson, is recruiting for an Medical Safety Officer, Established Products to be located in Lisbon, Portugal.

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The Medical Safety Officer (MSO) is a physician with training or experience in Medical Safety, who reports into the Global Medical Safety (GMS) organization and has accountability for assessing the medical safety of Innovative Medicine products and strategically leading cross-functional matrix teams responsible for product safety and benefit risk oversight.

The MSO will report to the Therapeutic Area (TA) Safety Head and oversee the safety 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 their products within the TA. The MSO will communicate potential and known risks, when appropriate, to TA Safety Head, Chief Safety Officer (CSO), Chief Medical Officer (CMO), Qualified Person for Pharmacovigilance (QPPV), 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 Innovative Medicine products.

**Responsibilities include, but are 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.
- 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 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.
- 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)/Periodic Safety Update Report (PSUR).
- Health authority queries.
- Core Data Sheets (CDS).
- 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 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 a 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.
- Perform delegate responsibilities for other MSOs and/or SMT Chairs

**Qualifications**:
**Education