Johnson & Johnson Careers
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Cross Sector SONIC Team Lead
Requisition ID: 1805651209W
Case processing & HA reporting –
· Processing and management of all adverse events reports in accordance to global and regional procedures
· Submitting regulatory reports to applicable regulatory authorities
· Ensuring completion all required trainings prior to performing tasks
· Responding to queries from CSL, LSO, OCMS and/or GMO and its service providers
· Supporting CSL, LSO OCMS and/or GMO in investigation or documentation of Quality Investigation as needed
· Any other pharmacovigilance duties, tasks or projects as assigned and agreed upon
· Ensure that local processes, procedures and systems are in place for tracking and processing for Adverse Events (AE) and other safety information reportable to GMS and OCMS from spontaneous, and solicited sources.
· Ensure comprehensive data processing to provide a complete description of the safety event.
· Ensure that patient confidentiality and privacy in accordance with local applicable laws and regulations are adhered to and if necessary, performed by redaction of patient information.
Collaborate & Support –
· Collaborate with CSL and LSO for adverse event reports processing and management.
· Provide technical and strategic input and participate in projects led by ASPAC IPV team work streams.
· Ensure that a process is in place for reporting of AEs after hours, and testing is documented as per Global and Regional requirements
· Ensure that a disaster recovery /business continuity plan is established in a risk-based manner to allow for continuation of critical business processes for PV
Team Management –
· Maintain oversight of all required PV reporting compliance in a timely manner.
· Escalate compliance issues in a timely manner to ASPAC Cross Sector Safety Lead to ensure appropriate mitigation is implemented.
· Monitor and forecast workload to identify, mitigate and escalate potential resource and non-compliance issues.
· Identify periods of high workload and manage resource appropriately to address them.
· Support and lead process improvements to optimize the system and make best use of resource.
· Work collaboratively with regional affiliates to ensure consistency of approach across groups.
· Build and maintain effective business relationships across ASPAC region to support the implementation of safety standards.
· Maintain an environment of continuous improvement within the team and contribute to continuous improvement initiatives across the region and globally with GMO, GMS and OCMS.
- Experience working in pharmacovigilance, knowledge of adverse event reporting in post-marketed products and clinical trials and knowledge Asia Pacific regulatory authority regulations
- Medical, pharmacy or life-sciences master degree (or above)
- Previous experience of working within the pharmaceutical industry on pharmacovigilance is preferred
- Excellent communication skills
- Excellent organisational skills
- Excellent team working skills
- Project management skills
- Time management skills
- Excellent command of written and spoken English
Xian-Janssen Pharmaceutical Ltd. (7043)