Global Pharmacovigilance (PV) Scientist, Senior Manager

BioSpace; Washington (District of Columbia); On-site; USD 140,000 - 190,000; Full time

Job summary

Amgen in Washington, DC seeks a Global Pharmacovigilance Senior Manager to lead safety assessment activities within Therapeutic Safety Teams and oversee pharmacovigilance operations across products.

The role emphasizes planning, review of aggregate safety data, risk management, regulatory submissions, and cross-functional collaboration to protect patient safety and maintain inspection readiness.

Qualifications

• Pharmacovigilance experience in industry aligned to degree level.
• Demonstrated understanding of safety reporting and regulatory expectations.
• Experience across multiple PV activities and cross-functional collaboration.

Responsibilities

• Directs planning, preparation, writing and review of aggregate safety reports.
• Oversees liaison activities with affiliates and internal Amgen partners on product safety.
• Reviews AEs/SAEs and contributes to study safety data listings and tables.
• Contributes to study risk management and regulatory safety responses.
• Supports inspection readiness and regulatory inquiries related to PV activities.

Education

Doctorate degree

Masters degree

Bachelor's degree

Associates degree

High school diploma/GED

Job description

Job Description

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Global Pharmacovigilance Senior Manager

What you will do

Lets do this. Lets change the world. In this vital role you will work with the Therapeutic Safety Teams for safety assessment activities for medical/scientific operations.

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
• Develop or update strategy and content for regional risk management plans
• Assist GSOs to oversee risk minimization activities including tracking of activities as needed.
• Evaluate risk minimization activity
• Prepare response to regulatory inquiries related to risk management plans under the guidance of GSO
• 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
• Inspection Readiness
• 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

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The pharmacovigilance professional we seek is a leader with these qualifications.

Basic 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

Preferred Qualifications