[Consumer] Associate, Drug Safety (Contractor)

Job Purpose and Scope Fulfil the responsibility for the coordination and execution of post-marketing safety management activities for Johnson&Johnson KK (JJKK) Consumer products to ensure that all of local regulatory requirements, Johnson & Johnson’s statutory and ethical responsibilities are met. Managing local medical safety activities to: Oversee Japan Consumer product safety strategy and pharmacovigilance (PV) operations in Japan while maintaining highest level of compliance with local regulations and Johnson&Johnson global policies. Represent Consumer safety strategic and operational interests in Japan and serve as a key interface between global functions, regional leadership and the local operating companies (LOCs). Oversee Japan Consumer medical safety operational process in the country. Contribute to inspection readiness and training related to Consumer safety policies and procedures. Participate in product safety issue management with local and regional leaders Core Job Responsibilities: PRINCIPAL RESPONSIBILITIES Ensure mechanisms in place to collect and receive adverse events from the various source, in partnership with the customer call center and other functions involved. Ensure that local processes and systems are in place for tracking, processing, submission and conducting follow up for Adverse Events (AE) and other safety information. Manage external vendor for local case processing. Maintain oversight of all required PV regulatory reporting compliance in a timely manner. Ensure all required documents related to PV departmental activities are retained according to regulatory requirements. Ensure all local PV quality documents are reviewed and updated as applicable. Escalate compliance issues in a timely manner to Line Manager in Japan and APAC Cross Sector Safety Lead to ensure appropriate mitigation is implemented. Ensure PV inspection/audit readiness at the affiliate level at all times. Maintain awareness of local PV legislation and guidelines. Work collaboratively with other functions and regional affiliates to ensure implementation of new company policies and regulatory requirements. Qualifications Qualifications Essential Knowledge & Experience 1~3 years’ experience working in the pharmaceutical industry OR CRO is strongly preferred; PV related experience is an advantage Ability to work independently but collaboratively in a matrix organization Extensive experience in conducting training Knowledge of PV regulations Experience using global safety database desirable Demonstrated attention to detail Excellent written and spoken communication and presentation skills. Qualifications Builds and maintains strong relationships with non-PV colleagues (e.g. Medical Information, Regulatory Affairs, Commercial) Learns fast, grasps the "essence" and can change course quickly where indicated Raises the bar and motivates others to a higher standard of performance Creates a learning environment, open to suggestions for improvement Embraces the ideas of others, nurtures innovation and manages innovation to reality Deals comfortably with ambiguity and uncertain risk Acts consistently within J&J Credo and local laws Focuses on compliance; identifies, manages and escalates issues in a timely manner Excellent organizational and project management skills Reacts quickly and effectively in a fast paced, dynamic environment Johnson & Johnson announced plans to separate our Consumer Health business to create a new publicly traded company. The process of the planned separation is anticipated to be completed within 24 months, and it will be subject to legal requirements including consultation with works councils and other employee representative bodies, as required, and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of a new entity within New Consumer Health and your employment would be governed by New Consumer Health’s employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by New Consumer Health at an appropriate time and subject to any necessary consultation processes. Johnson & Johnson Family of Companies in Japan strongly recommends prospective employees to complete the COVID-19 vaccination before or as soon as after joining our company to prevent the spread of infection among our employees and people around them as well as our customers and the community we serve, and to ensure our responsibilities are sustainably fulfilled as a healthcare company (except for those who cannot vaccinated Primary Location Japan-Tokyo-To-Chiyoda- Organization Johnson & Johnson K.K. (8235) Job Function General Administration Requisition ID 2206014301W