Amgen Global Safety Mgr in Thousand Oaks, California
Amgen is searching for a Global Pharmacovigilance (PV) Scientist to work in either our Thousand Oaks, CA location or our Cambridge, MA location. The Global PV Scientist will report to the Global Safety Director.
The Global PV Scientist works with the Therapeutic Safety Teams for safety assessment activities for medical/scientific operations. This person will also provide scientific and compliance expertise to Global Patient Safety (GPS).
The PV Scientist is responsible for the following:
Contributes to the planning, preparation, writing and review of aggregate safety reports.
Works with affiliates and other internal Amgen partners regarding deliverables.
Review of adverse events and serious adverse events from clinical trials.
Review and provide input and support on study protocols, statistical analysis plans and other clinical study-related documents.
Review standard design of tables, figures, and listings for safety data from clinical studies.
Participate in development of safety-related data collection forms for clinical studies.
Attend study team meetings as requested.
Conduct signal detection, evaluation, and management.
Perform data analysis to evaluate safety signals and write up analysis results in collaboration with the Global Safety Officer (GSO).
Prepare safety assessment reports and other safety documents and regulatory responses.
Search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection.
Participates in Safety Governance per Amgen processes.
Prepare presentation of the Global Safety Team's recommendations on safety issues to the cross-functional decision-making body.
Assist GSOs and other Senior Scientists in the development of risk management strategy and activities.
Provides contents for risk management plans.
Update strategy and content for regional risk management plans.
Assist GSOs to oversee risk minimization activities including tracking of activities.
Evaluate risk minimization activities.
Prepare response to regulatory inquiries related to risk management plans under the guidance of the GSO.
Support activities related to new drug applications and other regulatory filings.
Assist GSOs and other Senior Scientists in developing a strategy for safety-related regulatory activities.
Provide safety contents for filings.
Performs other duties related to the position as defined in Standard Operating Procedures or as requested by his/her supervisor.
Undertake activities delegated by the Qualified Person For PV (QPPV) as detailed in the PV System Master File and maintains a state of inspection readiness.
Be the representative and point of contact for Health Authority Inspections and Internal Process Audits within the remit of role and responsibility.
Contribute to the development, improvement, and standardization of PV processes and methods.
Participates on teams for the implementation of new processes and methods within the Therapeutic Area.
Master's degree and 3 years of Scientific experience
Bachelor's degree and 5 years of Scientific experience
Associate's degree and 10 years of Scientific experience
High school diploma / GED and 12 years of Scientific experience
1+ year Drug Safety/PV Experience
Experience in signal detection, evaluation and management
Experience as a contributor to periodic aggregate safety reports
Experience with literature surveillance: source document review knowledge and skills
Experience with Argus safety database
Good clinical and scientific judgment
Clinical and/or medical research experience
Excellent written and verbal communication 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.