【Consumer】Japan Safety Associate -Dr. Ci Labo- (Contractor)

仕事内容


POSITION SUMMARY:

Fulfil the roles and responsibilities in coordination with Dr CiLabo Global Safety Integration Team, Country Safety Lead (JJKK Consumer Safety Control Manager) and Japan Dr CiLabo team for the safety integration of the Dr. CiLabo including local support of all essential and required Product Safety and Pharmacovigilance (PV) activities.

 

Support Country Safety Lead (JJKK Consumer Safety Control Manager) to fulfil the responsibility for the coordination and execution of all Pharmacovigilance (PV) activities for JJKK Consumer to ensure that all of Johnson & Johnson’s statutory, local regulatory requirements and ethical responsibilities are met.

 

PRINCIPAL RESPONSIBILITIES:

Provide local support for integration and liaison activities for the Dr. CiLabo PV System and PV-related Operations and Activities:

•Provide key local safety support for the DCL Safety Integration in Japan. Aligns and provides feedback to the DCL Global Safety Integration Team

•Liaises with DCL Global Safety Integration Team to provide key strategic integration processes to the local stakeholders (internal and external (vendors) to J&J)

•Aligns with local regulatory team to ensure DCL Global Safety Integration Team are aware of impacts of local HA regulations to the integration.

•Provides guidance to DCL Global Safety Integration Team on Japanese medicinal/non medicinal classifications

•Supports with the inclusion of the product names and/or ingredients and/or requirements into the JJKK Consumer Customer Relation Management system (GCC platform) and the Global Safety Database (PRISM). Have oversight, management and update to ensure portfolio list alignment between local DCL Integration Team and DCL Global Safety Integration Team

•Liaise with local Quality Complaints team to ensure local AEPQC collection process is in place

•Liaise with CCC (consumer call center) team to ensure aligned collection of AEPQC

•Provide local language translation support and be a Key Point of Contact (POC) for safety teams at DCL and any local vendors

•Coordinate with Local DCL team counterparts on the oversight and monitoring of reported AEPQCs; ensure to escalate any safety alerts/signals identified from reported AEPQCs of DCL portfolio to the Medical Safety Officer (MSO in Consumer) for further assessment

 

Provide local support for integration and liaison activities for all the relevant Safety-related information of the Dr. CiLabo Portfolio:

•Coordinate and liaise with the local J&J integration team and Local DCL team for information requests on safety-related background information for the DCL portfolio

oBuild and establish trust, good working relationships and regular communication channels with Local DCL team counterparts and the local J&J integration team

o Serve as the local Safety team intermediary and support clear communication and translation of safety information requests to the local J&J integration team and local DCL team

o Provide additional logistics and coordination support to the local J&J integration team and Local DCL team for any safety data that needs to be tested/ generated (e.g., product formula impurity testing, clinical safety testing)

• Coordinate with the DCL Global Safety Integration Team (Toxicology/Clinical Safety and Medical Safety representatives) on the required safety-related background information for integration of DCL products into internal J&J systems and in compliance to internal J&J Safety Standards

• Support coordination of language translation requirements (either through CON direct translation or through translator vendor services) for safety-related background information provided to the Global Safety Integration Team 

o Ensure that the collection of required safety information is implemented in compliance with the aligned integration timelines and provided to the DCL Global Safety Integration Team in a timely manner

• Support the tracking and monitoring of the J&J integration activities status updates and eventual completion for the DCL portfolio; support any required remediation steps and action points to ensure compliance to aligned integration timelines

Provide local support to the critical day-to-day responsibilities and activities of the Consumer Country Safety Lead (CSL) for Japan

• Provide additional, as needed support to the Japan CSL on the oversight of the Japan Consumer product portfolio and PV systems/processes, case processing and Health Authority (HA) reporting, local compliance process and activities, Pharmacovigilance (PV) agreements, research-related activities (RRA), audit and inspection readiness, PV training, business continuity and any other daily/ routine PV/safety activities.

 


資格

• Medical, pharmacy or life-sciences degree (or equivalent)

• 0-2 years of experience in PV essential; experience working in the pharmaceutical industry is strongly preferred

• 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

• Effective decision maker with the ability to assess impact of actions taken locally on the global PV system

• Fluency in written and oral English and Japanese Language in order to facilitate communications between the DCL team, local J&J integration team and the Global Safety Integration Team; also relevant for communications with GMO, regional Medical, other global functions, and Health Authority

• High customer orientation

• Strong commitment to compliance with the relevant rules and procedures, and to scientific quality and integrity

• Sound judgment, strong planning and organizational skills, and the ability to get things done

• Demonstrated strong sense of urgency

• Strong influencing skills with the ability to explain and defend a position which is in the best interests of patient safety



プライマリ場所
日本-東京都-千代田区-
組織
Johnson & Johnson K.K. (8235)
ジョブ
General Administration
Requisition ID
2005797769W