Medical Safety Officer, Established Products

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Job Function:
Product Safety

Job Sub Function:
Product Safety Risk Management MD

Job Category:
Scientific/Technology

All Job Posting Locations:
Lisbon, Portugal

Job Description:

Johnson & Johnson is recruiting for a Medical Safety Officer.  This position will be located in Lisbon, Portugal.

The Manager, 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 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.

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 Therapeutic Area (TA).

The MSO will help ensure communication of potential and known risks, when appropriate, to TA Safety Head, Chief Safety Officer (CSO), Chief Medical Officer (CMO), the 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 contribute to and supervise, when appropriate, 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:


* 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...