Team Lead Global Casemanagement

vor 2 Wochen

Frankfurt Am Main, Deutschland BI International GmbH Vollzeit

**The Position**:
Boehringer Ingelheim is seeking a dynamic and experienced professional for the role of Teamlead Global Casemanagement in PSPV Operations. In this pivotal role, you will lead a dedicated team, identifying staffing requirements, defining training needs, and evaluating employee performance. Under the guidance of the Global Lead GCM, you will ensure that all product safety information is meticulously collected, documented, processed, and reported, adhering to our business standard operating procedures, working instructions, and global regulations.

Your role is crucial in managing the adverse event case handling workflow in our Global Safety Database. This includes overseeing the receipt and entry into the database, as well as the clinical assessment, and associated training. Your leadership and expertise will ensure the regulatory compliance of PSPV Operations, making a significant contribution to our commitment to improving patient safety.

***Tasks & responsibilities**:
As a Teamlead Global Casemanagement in PSPV Operations, you will:

- Direct and oversee Operations staff for the correct collection and reporting of individual reports of adverse events for investigational and marketed drugs to assure compliance with global regulations. This will include steering the day-to-day case processing workflow.
- Participate in the preparation and management of regulatory inspections within PSPV.
- Supervise and develop employees within your team, also serving as a mentor and resource to PSPV staff regarding processes, documentation, adverse event data evaluation, and decision-making.
- Ensure adequate resourcing of the tasks in the team and across the teams in GCM by using agile working methods. You will collaborate closely with the Senior Teamlead Global Casemanagement to coordinate vendor feedback and processes and with the Global Lead Study Coordination to ensure that studies and Clinical Trials are carried out as per set guidance.
- Function as a training expert for other PSPV functions and additionally provide training on the use of the database as a mentor and corresponding processes.
- Ensure study library data in the Global Safety Database are filled correctly and ensure smooth operations with regards to studies and clinical trials from set up to case processing and reconciliation.

***Requirements**:

- Master's degree in a health care/life science related profession or medical information science/data science
- Prior experience within the pharmaceutical industry in Pharmacovigilance
- Practical experience in case processing (solicited and post-marketing sources)
- Demonstrated leadership, problem-solving, analytical and teaching skills
- Strong communication skills
- Ability to make decisions independently
- Ability to communicate and resolve issues effectively with inter/intra departments through strong interpersonal skills
- Fluent in English

***Ready to contact us?**:
If you have any questions about the job posting or process - please contact our HR Direct Team,

Recruitment process:
Step 2: Virtual meeting in the period from beginning of July

Step 3: On-site interviews beginning mid of July

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