[Innovative Medicine] Country Safety Head Japan (Director Pharmacovigilance), Japan Local Safety Uni

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

Job Function:
Product Safety

Job Sub Function:
Pharmacovigilance

Job Category:
People Leader

All Job Posting Locations:
Chiyoda, Tokyo, Japan

Job Description:

The Country Safety Head is responsible and accountable for ensuring all pharmacovigilance requirements for Johnson & Johnson Innovative Medicine is fulfilled.

Provides strategic leadership to the teams to ensure and enable the achievement of the overall strategic imperatives of Local Medical Safety (LMS) in Japan.

  

 

Essential Job Duties and Responsibilities

Ensure patient safety and product safety for entire Johnson & Johnson Innovative Medicine products.

- Accountable for the compliance of the Pharmacovigilance activities including safety information intake & reporting to GMS/PMDA, PV agreements with business partner/vendor, and Risk Management Plan.

- Accountable for all GVP-related activities, either directly or through deputization, including activities such as:


* ​Development and implementation of Japan Risk Management Plan (J-RMP), conducting Early Post-marketing Phase Vigilance (EPPV), analysis of safety information, and monitoring of benefit risk balance


* Launch readiness of the products from safety aspects before approval of (supplemental) J-NDA


* Maintaining favorable benefit-risk balance of the marketed products, with timely communication of relevant safety information available to Health Care Professionals


* Planning proper safety measures, decide to implement the plan or make proposals on the plan to the Marketing Supervisor-General depending on the definition of the measure in the procedural documents


* Implementation and monitoring of risk management plans and take the appropriate actions for the implementation if urgent safety restrictions, as required.


* Ensuring GVP requirements and all updates are reflected in the procedural documents and put in place.

- Oversight Japan Product Safety Committee (JPSC)

- Build the strong communication and work closely with relevant stakeholders such as Marketing Supervisor-General, Quality Assurance Manager, PMS Control Manager, Head of Medical Affairs, Safety Operational Organization like Business Unit and partner companies.

Leadership and strategic direction of all activities in Japan Local Safety Unit (J-LSU)

- Provide strategic leadership and vision for J-LSU

- Strengthen organizational development such as such as building a high-performance & engage...