Reporting to the Head of Global Drug Safety Systems & Data Management, this position will be responsible for ensuring global Pharmacovigilance technology solutions and safety data needs are satisfied in accordance with applicable regulatory and DSPV (Drug Safety & PharmacoVigilance) requirements. This position will serve as a safety data management and safety database configuration expert and must possess working knowledge of overall drug safety processes, patient safety data, and Argus safety database.
- Support Data Management activities globally, including safety data outputs/line listings for PBRER/PSUR, DSUR, regulatory inspections, etc.
- Develop, provide support to create specialized reports from DSPV systems as appropriate
- Support Jazz Pharmaceuticals Global Safety Database system (JP-GSD) configuration and enhancments activities and maintain configuration documentation
- Support JP-GSD users and provide system administration support for global DSPV applications
- Work closely with DSPV Physicians, Safety Scientists, Safety Associates and PV Compliance staff globally to understand their technology needs and translate them into prioritized plans for action.
- Perform QC check on configuration changes; Identify discrepancies between the request and the implementation and resolve or initiate their resolution in collaboration with R&D IT and/or vendor(s)
- Coordinate with R&D IT and collaborate with vendor to provide resolution to identified and prioritized DSPV systems issues
- Provide DSPV systems and Data Management training to DSPV personnel as appropriate
- Understand DSPV processes to support process improvement initiatives
- Support Head of DSPV Systems and other DSPV Senior Management members in discussions to help business anticipate future needs and opportunities and communicate where technology can help
- Work with Head of DSPV Systems to raise new project proposals and support definition of the business case, conduct assessments of processes and detail requirements
- Collaborate with project team and other members of the DSPV systems and data management team to determine scope, goals and objectives in DSPV-related projects
- Collaborate with R&D IT and project team to define solutions that deliver business value
Required Knowledge, Skills, and Abilities
- 3+ years working knowledge / experience in managing Argus safety database, with advanced knowledge of Argus Console
- 3+ years of experience in Pharma Drug Safety / Pharmacovigilance
- Experience of working on Drug Safety systems projects, GXP and validation requirements
- Experience of retrieving data from relational databases
- Medical terminology and MedDRA knowledge
- English (fluent verbal and written)
- Preferred - Experience with safety data management and data analytics
- Preferred - Experience with BI tools
Required/Preferred Education and Licenses
- Life science, biomedical or computing degree (B.Pharm, B.Tech, B.E, MSc, MCA or higher)
- Required - Knowledge of Drug Safety and Pharmacovigilance function
- Required - Hands-on Argus PLSR configurations experience
Description of Physical Demands
- Occasional mobility within office environment.
- Routinely sitting for extended periods of time.
- Constantly operating a computer, printer, telephone and other similar office machinery.
Description of Work Environment
- Work indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes.
- Frequent computer use at workstation.
- May move from one work location to another occasionally.
- Responsibilities may require a work schedule that may include working outside of “normal” work hours, in order to meet business demands.
- Occasional public contact requiring appropriate business apparel.
Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.