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

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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 & engaged team through effective change management and fostering an inclusive culture to enable achievement of strategy and vision.

- Direct and has oversight of all Japan safety processes and activities through a professional management staff of Senior Managers and Managers.

- Ensure robust hiring of qualified staff for the Unit with optimal resource management and prioritization across the Unit. Responsible for supporting talent development and providing opportunities for growth.

As a member of the APAC LMS Leadership Team

- Contribute to developing and driving the mission and vision of APAC LMS through active engagement in regional safety initiatives and projects

- Establish strong relationships with regional stakeholders.

- Deputies for Regional Safety Head if required

Minimum Qualification

• Bachelor Master PhD or other equivalent advanced degree in a biological or medically related field is required and MD is preferable.

• At least 10 years or more experience in the pharmaceutical industry with a minimum of 5 years of direct team management preferably of large teams.

• At least 3 years experience in safety management activities or similar duties with experience of negotiation skills with regulators

• Comprehensive Knowledge of Japan PV regulations is required; knowledge of worldwide regulations is desired

• Highly effective written oral and interpersonal communication skills in Japanese and fluency in English is required

• Demonstrated ability to think strategically lead through change and build teams.

• Demonstrated innovative thinking to allow for optimal design and implementation of global safety strategies.

• Must have strong managerial influencing and communication skills necessary to act as a liaison with other disciplines and outside organizations.

• Experience in a cross cultural/global environment necessary.

For Internal Applicants

• Based on your experience and interview evaluation the position title and level may vary.

• If you are Japan employee please read Internal Application Guideline in Ask GS. Especially if you are less than 18 months in your current role you are required to obtain application approval from your current manager as well as your respective BUHR. If you are Japans employee you are not able to apply for multiple positions at once.

• For Employee Referral Program (ERP) please read and understand the details of theInternal Referral Overview on the Ask GS and you have made a compliant referral.