Global Pharmacovigilance (PV) Scientist
Career Category Safety 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) Scientist What you will do Let’s do this. Let’s change the world. In this vital role you will join a team of PV Scientists working in collaboration with Global Safety Officers (GSO) to provide the safety strategy and major safety deliverables for Amgen product. The Immuno-oncology team has an exciting portfolio of products ranging from Early Development through the Post marketing settings. We need collaborative and innovative world-class talent to ensure these molecules and medicines reach their full potential while helping patients.
Responsibilities
- Contributes to the planning, preparation, writing and review of periodic 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 or needed
- Conduct signal detection, evaluation, and management
- Perform data analysis to evaluate safety signals and write up analysis results in collaboration with 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 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/ or other Senior Scientist in developing a strategy for safety-related regulatory activities
- Provide safety contents for filings
- Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by the supervisor What we expect of you We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a scientist with these qualifications. Basic Qualifications:
- Doctorate degree OR
- Master’s degree and 2 years of relevant experience OR
- Bachelor’s degree and 4 years of relevant experience Preferred Qualifications:
- Healthcare professional background
- 1 year of 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 the Argus Safety database
- Good clinical and scientific judgment
- Clinical and/or medical research experience
- Strong written and verbal communication skills What you can expect from us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health an
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