Overview
To ensure high quality of ICSR (Individual Case Safety Report) processing and reporting and in compliance with external regulations and Boehringer internal procedures.
Team contribution to ensure that delegated operational tasks of the local Boehringer Ingelheim Pharmacovigilance System are performed in a timely manner and checked periodically as required in line with local regulatory requirements and Boehringer internal processes.
Close cooperation with Boehringer-internal interfaces and proactive support of people contacting Patient Safety & Pharmacovigilance(PSPV)department China with regards to Pharmacovigilance related matters.
What you will be doing
• Execution of all ICSR processing (e.g. ICSR collection, ICSR processing, follow-up) and reporting is compliant with respective Boehringer procedures:
• Case classification, intake, and local review of Patient Safety relevant information in Global Safety Platform.
• Coordinates the medical review of incoming case information, where required.
• Ensure high quality translation of the case receiving in local language or in case with complex information (where feasible within the required timelines).
• 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 Boehringer timelines and properly document in Global Safety Platform.
Qualifications
• Ability to prioritise workload and perform under stress in situations in which working speed and sustained attention are critical aspects of the job
• Good technical understanding and experience in working with databases
• Ability to converse with other medical professionals to collect, interpret and reconcile complicated medical data
• Good communication / interpersonal and organisational skills
• Problem solving skills and the ability to organize time effectively
• Ability to work efficiently in a team