Johnson & Johnson Careers
Manger, Safety Operations, CCS
Beijing, China; Beijing, China
Drug & Product Safety Operations
Requisition ID: 1805675821W
• Oversight of the full cross sector product portfolio, and link with local management and key stakeholders
• Maintain oversight of all required PV regulatory reporting compliance in a timely manner.
• Advise the business on the PV impact of local organized data collection programs.
• Escalate compliance issues in a timely manner to Line Manager and APAC Cross Sector Safety Lead to ensure appropriate mitigation is implemented.
• Monitor and forecast PV workload to identify, mitigate and escalate potential PV resource and non-compliance issues.
• Identify periods of high PV workload and manage PV resource appropriately to address them.
• Support and lead process improvements to optimize the PV system and make best use of PV resource.
• Work collaboratively with regional affiliates to ensure consistency of approach across groups.
• Build and maintain effective business relationships across the LOC to support the implementation of safety standards.
• Provide high quality and consistent input to development of local safety initiatives and programs.
• Plan and deploy skilled resources against project priorities, if applicable
• Maintain an environment of continuous improvement within the PV team and contribute to continuous improvement initiatives across the region and globally with GMO, GMS and OCMS.
• Ensure compliance with the CAPA process for the reporting and investigation of exceptions (nonconformance, potential nonconformance and planned deviations).
• Ensure a local tracking system is in place to ensure timely submissions of adverse events (AEs) to GMS.
• Ensure reporting of both clinical and post-marketing individual case safety reports (ICSRs) and periodic reports to the regulatory authority as required (and ethics committee, if applicable).
• Report monthly compliance metrics and information to QPPV Office, GMS, International PV, Compliance, Strategy and Analytics (CSA), and BQ within the required timelines
• Maintain awareness of local post-marketing and clinical PV legislation and guidelines
• Ensure Line Manager/APAC Cross Sector Safety Lead, and PV Policy Group are promptly notified of any changes to relevant local legislation.
• Ensure formal documentation and notification to PV Policy Group of local reporting requirements for both ICSRs and aggregate reports, provide updates to these requirements per changes in local legislation, and review and confirm these requirements at least annually.
• Coordinate affiliate review and submission of PSURs & DSURs.
• Ensure any changes to affiliate safety personnel are communicated to the Health Authority (i.e. nominated contact person for PV), GMS, OCMS and IPV in a timely fashion.
• Complete AE reconciliation with interacting departments and/or partner companies (if applicable) and act upon any discrepancies
• Review and confirms regulatory reporting requirements at least bi-annually
• Medical, pharmacy or life-sciences degree (or equivalent)
• 4-5 years of experience in PV essential; experience working in the pharmaceutical industry is strongly preferred
• 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
• Effective decision maker with the ability to assess impact of actions taken locally on the global PV system
• Fluency in written and oral English in order 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)
Drug & Product Safety Operations