Global Pharmacovigilance (PV) Senior Scientist

Career Category

Job Description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll 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, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Global Pharmacovigilance (PV) Senior Scientist

What you will do

Let’s do this. Let’s change the world. The Global Safety Therapeutic Area Teams serve as the safety experts for all Amgen products globally and are accountable for the safety strategy and major safety deliverables for each Amgen product. Amgen is seeking a Global Pharmacovigilance (PV) Senior Scientist to work out of their Thousand Oaks, CA facility. The Global PV Sr. Scientist works with the Therapeutic Safety Teams for safety assessment activities for medical/scientific operations. This person will also provide scientific and compliance expertise as needed to Global Patient Safety, in the establishment of a highly effective global safety organization in full compliance to worldwide regulations.

The Senior Scientist is responsible for the following:

• Directs the planning, preparation, writing and review of portions of aggregate reports
• Organizes and directs liaison activities with affiliates and other internal Amgen partners regarding product safety
• Supports and provides oversight to staff with regards to safety in clinical trials
• Reviews and provides input and support on study protocols, statistical analysis plans and other clinical study- related documents
• Reviews Adverse Event/Serious Adverse Event (AEs/SAEs) from clinical trials
• Reviews and provides input on standard design of tables, figures, and listings for safety data from clinical studies
• Participates in development of safety-related data collection forms for clinical studies
• Participates in study team meetings
• Performs data analysis to evaluate safety signals and writes up analysis results for signal detection, evaluation and management
• Authors Safety Assessment Reports and other safety documents and regulatory responses in collaboration with the Global Safety Officer (GSO)
• Prepares presentation of the Global Safety Team’s recommendations on safety issues to the cross-functional decision-making body
• Provides content for risk management plans
• Develops or updates strategy and content for regional risk management plans
• Assist GSOs to oversee risk minimization including tracking of activities and developing a strategy for safety-related regulatory activities
• Prepares response to regulatory inquiries related to risk management plans under the guidance of GSO
• Undertakes activities delegated by the Qualified Person for Pharmacovigilance (QPPV) as detailed in the PV System Master File and maintain a state of inspection readiness
• Be a representative and a point of contact for Health Authority Inspections 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 professional we seek has these qualifications.

Basic Qualifications:

Doctorate degree and 2 years of Scientific clinical experience or current Pharmacovigilance or Drug Safety experience or Biotech/Pharmaceutical experience

Or

Master’s degree and 4 years of Scientific clinical experience or current Pharmacovigilance or Drug Safety or Biotech/Pharmaceutical experience

Or

Bachelor’s degree and 6 years of Scientific clinical experience or current Pharmacovigilance or Drug Safety or Biotech/Pharmaceutical experience

Or

Associate’s degree and 10 years of Scientific clinical experience or current Pharmacovigilance or Drug Safety or Biotech/Pharmaceutical experience

Or

High school diploma / GED and 12 years of Scientific clinical experience or current Pharmacovigilance or Drug Safety or Biotech/Pharmaceutical experience

Preferred Qualifications: