Description

　　Our Global Patient Safety System Business Solutions team is responsible for developing and enabling system driven processes with all business units of Boehringer Ingelheim Medicine. We work in international, cross-functional teams directly with the cloud solution software provider and other customers in the multi-tenant setting and explore and harness the potential of technology for our business. We are a group that lives the principles to boldly drive innovation and be front runners in implementation of new technologies and process approaches.

　　As a Data Retrieval Manager within the Regulatory Reporting Team, you will work with data and build processes based on applications related to all the task that support a well-functioning and compliant Pharmacovigilance system. You will work cross-functional with many teams in the Patient Safety Department globally to retrieve data and to fulfil global and local regulations.

　　Duties & Responsibilities

　　With your technical, project management and business application knowledge you will lead and oversee designing, implementing, validating and training of the Global Safety Platform (GSP). You will conceptually plan solutions within the system directly with the vendor and other customers of the multi-tenant platform and with the business users within GPV and ONE Medicine.

　　You will be accountable to retrieve data out of Global Safety Platform to support global and local PV Process, audits and inspections. Your responsibility includes ensuring that the deliverables from the PV system are fulfilling the regulations and are 100% accurate and establishing proper Quality measures for such process.

　　In your role, you will proactively investigate further needs of our business functions to ensure they are compliant with Corporate procedures as well as global and local regulations.

　　You will use your knowledge of emerging technologies as they pertain to the GSP functionalities and artificial intelligence methods to ensure continuous improvement of the GSP and sustainability of the GSP processes.

　　Finally, you will represent BI in cross functional working groups touching the processes that the GSP supports and will work with system users within the pharmaceutical industry or regulatory authorities.

　　Requirements

　　Bachelors degree or higher from an accredited institution in computer science or related health care field required.

　　In the absence of a Bachelor degree, the minimum of eight (8) years of direct experience in pharmacovigilance data retrieval is required.

　　Minimum of one to three (1-3) years of pharmaceutical industry experience, with one (1) year of experience in pharmacovigilance preferred.

　　Technical skills to include a strong working knowledge of SQL, report writing/query extraction tools such as, Oracle Forms/Reports or SAS preferred.

　　Working knowledge of FDA regulations preferred.

　　Ability to make decisions independently.

　　Ability to prioritize workload and perform under stress in situations in which working speed and sustained attention are critical aspects of the job required.

　　Must be able to communicate and resolve issues effectively with inter/intra departments through strong interpersonal skills.

　　Proficient in electronic data capture tools (i.e. ARISg), clinical databases (i.e. CTMS/CTMF), and Microsoft-based applications(i.e., Word, Excel, PowerPoint).

　　Must have problem solving skills and the ability to organize time effectively.

　　Understand how to generate reports based on global regulatory requirements as well as determining the best report(s) to provide to fulfill report requests from both internal and external requesters.

　　Understanding on how reports function to ensure all applicable information is captured.

　　Must have a good understanding of Pharmacovigilance regulations, processes and procedures as it applies to the generation and distribution of reports and line listings.

　　Compensation

　　This position offers a base salary typically between $111,000 and $183,000.  The position may be eligible for a role specific variable or performance based bonus and or other compensation elements.  For an overview of our benefits please click here. (https://www.boehringer-ingelheim.com/us/careers/benefits-rewards)

　　All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.