Amgen Director Pharmacovigilance Operations: Safety Information and Data Management in Thousand Oaks, California
Amgen is seeking a Director Pharmacovigilance Operations to work out of their Thousand Oaks, CA or Cambridge, MA location.
The Director Pharmacovigilance Operations ensure that Pharmacovigilance (PV) Operations Safety Systems and processes fulfill the desired compliance, business process, data integrity, quality, and security objectives globally and cross-functionally.
The Director of PV Operations additional responsibilities are:
To ensure the organizational needs for data and PV Operations Safety Systems are met.
Provide technical and managerial leadership to a global team of technical staff ensuring close interaction with the end-user community with the objective of delivering high quality, compliant, validated and timely solutions.
Implementation and management of changes to safety systems. Act as the primary business contact and owner of PV Operations Safety Systems for requirement development, design, implementation and validation of PV Operations Safety Systems, as needed.
Responsible for development, implementation and oversight of processes and procedures relating to effective management of global PV Operations Safety Systems with the objective of maintaining their validated state. This includes providing metrics measuring the efficiency and effectiveness of the team.
Develop robust information and data management strategies.
Work in a highly collaborative manner with team members to understand their needs and translate them into prioritized plans for action.
Provide business oversight and guidance for development and management of information and data management processes and documentation.
Drive the implementation of pharmacovigilance data requirements through cross-functional governance bodies that oversee data exchange with pharmacovigilance systems within remit.
Manage individual and group projects of moderate to high complexity.
Oversee the development and implementation of comprehensive data and PV Operations Safety Systems related training.
Responsible and accountable for timely escalation of issues and concerns that impact PV Operations Safety Systems, collaboration and efficient working of the team to the Head of PV Operations.
Work closely with all functional areas to develop solutions, work plans and oversee their implementation, including but not limited to gathering, business requests for PV Operations Safety Systems, changes and upgrades. Provide subject matter expertise for PV Operations Safety Systems upgrades and changes.
Develop effective relationships with IS and external vendors to ensure successful execution of information and data management strategies within pharmacovigilance systems.
Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness.
Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility.
Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by his/her supervisor.
Doctorate degree and 4 years of drug safety/PV operations, clinical development, clinical operations experience
Master's degree and 8 years of drug safety/PV operations, clinical development, clinical operations experience
Bachelor's degree and 10 years of drug safety/PV operations, clinical development, clinical operations
4 years of managerial experience directly managing people and/or leadership experience leading team, projects or programs
5+ years direct experience supporting successful global Safety databases, data migration, management and/or implementations for large or medium-sized Pharma.
Experience must include reviewing business process and requirements analyses with a strong focus on ensuring customer satisfaction.
Demonstrated knowledge and experience in implementing solutions to meet global Clinical Trial/Pharmacovigilance regulatory requirements in safety systems
Demonstrated ability to manage multiple concurrent projects.
5+ years strong project management knowledge and experience.
In-depth knowledge of MedDRA and WHODrug coding dictionaries
In-depth knowledge of Clinical Trial and Pharmacovigilance Processes
Understanding of clinical trial Electronic Data Capture (EDC) systems, clinical trial coding systems, and dictionary query management systems
Understanding of Safety systems (ARISg, Argus, or equivalent)
Understanding of software development lifecycle and development standards, including validation methodology
Understanding of global regulations for pharmacovigilance and safety reporting
Experience interacting with regulators during inspections
Understands impact of emerging scientific/technical trends and their implications for Amgen
Experience creating insightful and progressive functional strategy (multi-year)
Problem solving and process improvement/change management experience
Organization, prioritization, planning and measurement of work deliverables
Ability to build relationships and work cross-functionally
Strong communication, collaboration and leadership skills
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.