Patient Safety Executive

The Position

• Team contribution to ensure the maintenance of a local pharmacovigilance (PV) system to support patient's and clinical trial subject’s safety and public health in Malaysia, Singapore, Brunei and to provide support for Indonesia territory (when applicable/ when needed)
• Self-dependent execution of Individual Case Safety Report (ICSR) processing in high quality and in line with local regulatory requirements and BI internal processes
• Team contribution to ensure that all delegated operative tasks of the local BI
• Pharmacovigilance (PV) System are prioritized, performed in a timely manner and are regularly checked according to the current BI processes.
• Close cooperation with Boehringer Ingelheim-internal interfaces and proactive support of people contacting PV in Malaysia, Singapore, Brunei and Indonesia with regards to Pharmacovigilance related matters
  
  
  

Duties and Responsibilities

Compliance:

Self-dependent execution and team contribution for management of PV relevant information received locally (e.g. ICSR collection, local processing, follow-up, reconciliation, documentation, and archiving) including PV reporting to local Health Authorities/ Ethics Committees in line with applicable regulations and respective processes:

• Intake, case classification and local review of Patient Safety relevant information in Global Safety Platform
• Provides high quality translation of the case receiving in local language or in case with complex information (where feasible within the required timelines) coordinates the translation with the external vendor, where applicable
• Ensures personal information is redacted from source data in line with data protection requirements
• Queries concerning case information (=Follow up) are sent out within the valid company’s timelines and properly document in Global Safety Platform
• Queries are easy to understand for external customers and targeted to the missing information (e.g. by prepopulating forms / questionnaires with available information)
• ICSR Submission to local Health Authorities and /or the Ethic Committees/Institutional Review Board (IRB) is performed in line with the company’s processes and regulatory requirements
• Provide feedback to LPSL on any discovered findings on enhancement of ICSR processing process.
  
  
  

Quality:

Contributes to the quality of the local PV system by taking over and executing the following tasks in line with the company’s processes and timelines:

• Support of Pharmacovigilance training including translation of global training material into local language
• Conduct website screening/tests of Boehringer Ingelheim websites regarding the correct reporting of PV relevant information
• Conduct CRM Screening for patient safety relevant information
• Perform Out of Office (OoO) test calls by our internal interfaces and external Vendors, which are contributing to the 24 hours availability
• Support of local inspections/audits and participation in PV audits and PV inspections as requested
• Screens local scientific literature for identification of PV relevant information
• Archiving:
• All relevant documents are independently archived in a timely manner in accordance to Boehringer Ingelheim processes and regulatory requirements.
• External Archive: Archive retrieval checks are performed independently and timely and are documented
  
  
  

Collaboration and contribution:

• Support the implementation activities to enhance PV compliance culture and PV awareness at local level of the organization in line with global recommendations
• Support of local inspection/audit readiness and participation in PV audits and PV inspections as requested
  
  
  

Functional knowledge:

• Complete assigned Learning One Source (LOS) as per curricula on time
  
  
  

Requirements

• Life-Science degree is acceptable
• Having PV experience is an advantage
• Demonstrated ability to multi-task and work in a diverse fast-paced environment
• Demonstrated ability to be goal oriented, prioritized, innovative/creative and the desire to constantly learn.
• Good in communication skills and English