Amgen Pharmacovigilance Operations Manager in Cambridge, Massachusetts
Amgen is seeking a Pharmacovigilance (PV) Operations Manager to work out of the Cambridge office under the direction of the Director. The PV Operations Manager works on projects and process that ensures the strategies of the department are executed into the safety related organized data collection activities in Amgen clinical trials and commercial activities (eg patient support programs and market research) to ensure Amgen remains compliant with global safety legislation and requirements.
The responsibilities of the PV Operations Manager Include:
Accountable for the review, approval and execution of PV Operations safety data collection strategy across clinical trial and commercial programs.
Responsible for participating in cross-functional activities to ensure and promote compliance with pharmacovigilance data collection standards and operational consistency across clinical trials and commercial programs for all Amgen products.
Provide knowledge into Clinical and Commercial teams on the needs and timelines of safety related organized data collection to ensure these needs are met and incorporated into Amgen studies and commercial activities/programs that may generate adverse event data.
Accountable as liaison between clinical trial and commercial programs (patient support and market research) and Global Patient Safety to ensure capture of all adverse event data generated by such programs and activities.
Undertake activities delegated by the Qualified Person for Pharmacovigilance (QPPV) as detailed in the PV System Master File and maintain a state of inspection readiness.
Participates in the creation and dissemination of appropriate safety reporting language in commercial and clinical trial key documents.
Supports the department by being a liaison between clinical trial and commercial programs (patient support and market research) and Global Patient Safety to ensure capture of all adverse event data generated by such programs.
Support activities to ensure PV Operations input to commercial initiatives.
Accountable for reconciliation activities between Global Patient Safety and commercial programs to ensure reporting of all adverse event data.
Actively participates in cross functional projects that develop and support strong cross-functional relationships and communication.
Develops and communicates plans/objectives to others.
Maintains knowledge of adverse event reporting process and safety system and contribute to the development, improvement and standardization of new processes and methods.
Contributes to projects which involve the implementation of new processes and methods within and across Global Patient Safety.
Maintain functional area standard operating procedures and contribute to R&D Standards documents as applicable.
Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness.
Provide input to Global Regulatory Affairs and Safety (GRAAS) contracting groups globally.
Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility.
Master's degree and 3 years of biotechnology and/or pharmaceutical experience
Bachelor's degree and 5 years of biotechnology and/or pharmaceutical experience
Associate's degree and 10 years of biotechnology and/or pharmaceutical experience
High school diploma / GED and 12 years of biotechnology and/or pharmaceutical experience
*Able to effectively represent ideas both verbally and in writing
*Sound knowledge of the global safety environment, regulations and guidance
*Project and/or Process Management experience & knowledge
*Sound understanding of safety data capture, representation and interpretation
*Sound knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery
*Able to apply multi-disciplinary knowledge and understanding to effectively collaborate and negotiate within function and cross-functionally
*Able to organize, plan and prioritize workload for the function
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.