Johnson & Johnson Careers
China Cluster Safety Head for Pharma & Consumer
Requisition ID: 1805660982W
• Oversee Pharma and Consumer product safety strategy and pharmacovigilance (PV) operations in China Cluster while maintaining highest level of compliance with local regulations and Johnson & Johnson global policies.
• Oversee development and implementation of local Risk Management Plans and proactively address any emerging safety concerns. Ensure fulfillment of safety obligations adopted as part of marketing authorizations and other commitments relating to the safe use of the products, including risk minimization measures and post-authorization safety studies requested by a health authority (HA).
• Oversee the Medical Safety team and ensure that J&J fulfils its obligation for medical safety to HA and Global Medical Organisation
• Build strong networks and collaborations with safety colleagues across all sectors in the China region.
• Engage in the development of Post Approval Safety Study protocols conducted locally.
• Represent Pharma and Consumer safety strategic and operational interests in China Cluster and serve as a key interface between global functions, regional leadership and the local operating companies (LOCs).
• Ensure responsibilities outlined in the Service Level Agreements between Pharma and Consumer safety organizations and the LOCs are mutually fulfilled with respect to product safety accountabilities.
• Oversee Pharma and Consumer medical safety operational and scientific centers in the China region.
• Contribute to inspection readiness and training related to Pharma and Consumer safety policies and procedures.
• Participate in product safety issue management with local and regional leaders and serve as a member of the China Quality, Safety & Compliance Council and the China Development LT.
• Member of Asia Pacific Cross Sector Safety Leadership team
• Medical, pharmacy or life-sciences degree with Ph.D. (Medical degree preferred)
• 13-15 years of experience in PV essential; experience working in the pharmaceutical industry is strongly preferred
• Resident of China and is permanently and continuously available (or at least within the hours of 9am–5pm GMT+8 Monday to Friday)
• Ability to conduct clinical assessments for adverse reactions, significant safety issues and the benefit–risk analysis of medicines in China
• Adequate understanding of the China and global pharmacovigilance processes in order to have effective oversight of the entire J&J pharmacovigilance system.
• Strong people management and leadership compatibilities
• Ability to build benchmark organisational capabilities
• Ability to work independently but collaboratively in a matrix organisation
• Extensive experience in conducting training
• 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 to facilitate 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
Xian-Janssen Pharmaceutical Ltd. (7043)