Major duties and responsibilities :
This role is responsible for creating and validating ad hoc reports and queries needed to support Pharmacovigilance and signal detection activities as well and the review of these reports and queries to verify that they are accurate and consistent with the request from the subject matter expert
This role encompasses many of the operational aspects within the System Support and Data Management unit. This role works directly with all GPV stakeholders, including GSOs, PV Scientists, to accurately interpret and translate business needs into the appropriate technical language to ensure that configuration, operations, validation, and / or analytic reporting deliverables meet business needs.
This role is responsible for the oversight and management of various aspects of the safety database system as well as direct involvement and oversight of projects designed to deliver enhancements, change controls and future tools to support GPE.
Additionally, the role will have oversight for multiple vendor activities supporting the SSDM team. The incumbent works with all Safety System and Data Management stakeholders to ensure accurate planning and execution of critical database system activities
The role can also participate in the configuration of the safety database as well as the development, validation and maintenance of the system enhancements including the generation and approval of documentation to support the customer methodology PUMA (Project Unified Methodology Approach).
It is important that the role has a strong PV knowledge and working relationships with the user community as well as the Information Technology (ITS) department.
Skills and Education :
Minimum of Ph. D. or Pharm D. (or equivalent experience) with a minimum of 10 years of pharmaceutical industry experience within R&D and / or pharmacovigilance.
Strong experience in Pharmacovigilance systems, Project Management, IS and validation is required. Incumbent should have experience in Pharmacovigilance Safety Data Management, including Analytical Reporting
BS degree (science, engineering, computer science) or previous experience in Pharmacovigilance Safety Database / validation experience working in a highly regulated environment
Additional Experience required :
Strong computer science technical skills are required. Strong pharmacovigilance data systems experience is required. In-depth knowledge of International pharmacovigilance requirements / EU, FDA requirements / international guidelines, ICH / CIOMS, with experience in their practical application In-depth understanding of pharmacovigilance processes, regulatory compliance and needs of standardization.
Knowledge of GCP and validation of computerized system methodology
Strong knowledge in pharmacovigilance principles and regulatory requirements.
Strong knowledge in Analytic Reporting processes, tools and data managment
Strong clinical as well as technical skills are required. Project Management skills as well as understanding of the different business functions within pharmacovigilance including case management, quality & compliance, signal detection, aggregate & analytical reporting.
Ability to lead and work within multi-disciplinary teams and interface with upper level management of support and client organizations.
Strong interpersonal skills to be effective in the leadership of global teams
Excellent critical data analysis skills (clinical / systems / processes / compliance)
Excellent teamwork and interpersonal skills
Excellent organizational and planning capabilities
Excellent communication skills (oral / written)
Knowledge and skills desirable but not essential :
Knowledge on a query tool (BI, Business Objects, OBIEE) desirable
Previous experience working with Argus safety database
Previous experience in computerized system methodology for implementation and validation of IT systems