Director, Medical Safety Officer, Oncology

Johnson & Johnson, is recruiting for a Director, Medical Safety Officer, Oncology to be located in Titusville, NJ; Raritan, NJ; or Horsham, PA. 

 

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.

Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

Learn more at https://www.jnj.com/.

 

We are Johnson & Johnson.

Our mission drives us.

Our patients inspire us.

We collaborate with the world for the health of everyone in it.

We are guided by our Credo.

 

Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion.

Proud to be an equal opportunity employer.

 

The Pharmaceuticals Medical Safety Officer (MSO) has accountability for assessing the medical safety of assigned Johnson & Johnson 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 Sr.

Director Product Safety Head, Oncology and oversee the safety and benefit/risk assessment of assigned products within the Oncology 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 Sr.

Director Product Safety Head, the VP Therapeutic Area Safety Head (TASH), 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 Johnson & Johnson 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 (e.g., Program Safety Analysis Plan)...