This position will be responsible for managing the safety systems team and ensuring safety business needs are satisfied in accordance with applicable regulatory and department requirements. This position will serve as a line manager to a global team and a safety database maintenance and configuration expert possessing working knowledge of overall drug safety processes, patient safety data, and Argus safety database.
- Manage the safety systems team and serve as the business systems owner ensuring ongoing support of safety systems globally
- Review safety systems issues, configuration changes, and/or other routine requests and aligns with the business process owner and IT system owner in prioritization activities
- Coordinate with System Administrator (Business & IT) as applicable to resolve/implement issues/requests relevant to in-scope activates and if necessary perform testing
- Interface with system end-users to identify necessary regulatory/compliance related system updates and guide the safety systems team in collaboration with the IT System Owner to address required configuration changes
- Co-approve changes to the safety systems
- Coordinate with IT and collaborate with vendor to provide resolution to identified and prioritized safety systems issues
- Support department leadership members in discussions to help business anticipate future needs and opportunities and communicate potential solutions
- Assist with new project proposals and support definition of the business case, conduct assessments of processes and detail requirements
- Collaborate closely with the R&D Analytics team to raise awareness of safety systems changes that could impact safety data
- Support safety systems users and provide system administration support for global safety applications
- Work closely with Safety Physicians, Safety Scientists, Safety Associates and PV Compliance staff globally to understand their safety systems 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)
- Enable safety systems training to personnel as appropriate
- Understand safety/PV processes to support process improvement initiatives
- Collaborate with project team and other members of the safety systems team to determine scope, goals and objectives in safety/PV related projects
- Collaborate with R&D IT, R&D Analytics, and project team to define solutions that deliver business value
Required Knowledge, Skills, and Abilities
- 5+ years working knowledge / experience in managing Argus safety database, with advanced knowledge of Argus Console
- 5+ years of experience in Pharma Drug Safety / Pharmacovigilance
- Experience of working on Drug Safety systems projects, GXP and validation requirements
- Medical terminology and MedDRA knowledge
- English (fluent verbal and written)
- People management skills
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, sexual orientation, gender identity, national origin, disability status, protected veteran status, or any characteristic protected by law.
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.