Global PV Senior Manager — Flexible Work Model

Initial Therapeutics, Inc.; United States; On-site; USD 150,000 - 210,000; Full time

Benefits offered by this job

Comprehensive benefits package

Retirement and savings plan

Flexible work options

Job summary

Amgen seeks a Global Pharmacovigilance Senior Manager in the United States to lead safety assessment activities and oversee aggregate reporting. You will coordinate with Therapeutic Safety Teams, affiliates, and internal partners to ensure robust signal detection, data analysis, and risk management.

The role requires advanced degrees with multiple years in pharmacovigilance, leadership experience, and strong regulatory knowledge.

Qualifications

• Doctorate degree and 2 years of industry pharmacovigilance experience.
• Masters degree and 4 years of industry pharmacovigilance experience.
• Bachelor's degree and 6 years of industry pharmacovigilance experience.
• Associates degree and 10 years of industry pharmacovigilance experience.
• High school diploma/GED and 12 years of industry pharmacovigilance experience.
• Bachelors in life science and Masters and 6 years of related experience
• 2 years of managerial experience directly managing people or projects and/or mentoring experience
• Clinical or medical research experience
• 6 years of experience in the biotech/pharmaceutical setting

Responsibilities

• Directs the planning, preparation, writing and review of portions of aggregate reports
• Organize and direct liaison for activities with affiliates and other internal Amgen partner regarding products
• Supports and provides oversight to staff with regards to safety in clinical trials to: Review and provide input and support on study protocols, statistical analysis plans and other clinical study-related documents
• Review of AEs/SAEs from clinical trials as needed
• 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
• Participate in study team meetings as requested or needed
• Signal detection, evaluation, and management- Perform data analysis to evaluate safety signals and write up analysis results
• Documents work as required in the safety information management system
• Author Safety Assessment Reports and other safety documents and regulatory responses in collaboration with the GSO
• Search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection
• Prepare presentation of the Global Safety Teams recommendations on safety issues to the cross-functional decision-making body
• Assist GSO in the development of risk management strategy and activities: Provides contents for risk management plans
• Assist GSO in the development of risk management strategy and activities: Develop or update strategy and content for regional risk management plans
• Assist GSO in the development of risk management strategy and activities: Assist GSOs to oversee risk minimization activities including tracking of activities as needed.
• Assist GSO in the development of risk management strategy and activities: Evaluate risk minimization activity
• Assist GSO in the development of risk management strategy and activities: Prepare response to regulatory inquiries related to risk management plans under the guidance of GSO
• Assist GSO in the development of risk management strategy and activities: Support activities related to new drug applications and other regulatory filings: Assist GSO in developing a strategy for safety-related regulatory activities, Provide safety contents for filings
• Assist GSO in the development of risk management strategy and activities: Inspection Readiness
• Assist GSO in the development of risk management strategy and activities: Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
• Assist GSO in the development of risk management strategy and activities: Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility

Skills

Pharmacovigilance

Leadership

Regulatory knowledge

Education

Doctorate degree

Masters degree

Bachelor's degree

Associates degree

High school diploma/GED

Job description

Amgen seeks a Global Pharmacovigilance Senior Manager in the United States to lead safety assessment activities and oversee aggregate reporting. You will coordinate with Therapeutic Safety Teams, affiliates, and internal partners to ensure robust signal detection, data analysis, and risk management.

The role requires advanced degrees with multiple years in pharmacovigilance, leadership experience, and strong regulatory knowledge.