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.
Patient Safety Agreement Management - Senior Associate
What you will do
Let’s do this. Let’s change the world. In this vital role you will contribute to standards around which others will operate. Responsible for the day-to-day operations for key activities. Supports the negotiation, implementation, maintenance and oversight of fulfilment and regulatory compliance of global PV Agreements (PVAs) with business partners
Provide administrative support to the PSAM team including
management of the PSAM group Mailbox
PVA management and documentation
Responsible for minutes during team and Business Partner meetings
Management of the PSAM SharePoint
Tracking and oversight of PV obligations in Pharmacovigilance agreements including tracking of non-conformance
Handles development of process related documentation to ensure compliance and efficiency
Drafting and negotiating amendments and terminations
Supports GPS function during audit/inspection
Mentors new staff in areas of expertise as needed
Share knowledge of all relevant regulatory guidance and standards (e.g. FDA, ICH and EMEA PMDA)
Provide hands-on contributions to team projects/cross-functional project teams and delivering on schedule
Provide a pro-active approach to initiatives within the pharmacovigilance department and in cross-functional efforts
Evaluate and implement new technologies and processes
Take on projects and roles as directed by the PSAM Manager and/or Director
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The professional we seek should have these qualifications.
Basic Qualifications:
Master’s degree and 1 to 3 years of directly related experience OR,
Bachelor’s degree and 3 to 5 years of directly related experience OR,
Diploma and 7 to 9 years of directly related experience
Excellent command of the English language (written and spoken)
Pro-active communicator
Strong technical competency
Strong attention to detail
Recognize and escalate issues
Time Management
Strong written communications
Strong Planning - Problem Solving
Strong Customer Focus
Building Effective Teams
Managing and Measuring Work
Strong Presentation Skills
Strong Interpersonal Skills
Process Management
Conflict Management
Organizational Skills
Global Business Knowledge
Microsoft Suite - Outlook, Word, Excel, PowerPoint (proficient)
Knowledge of Regulatory and Safety functional activities - Pharmacovigilance systems
Principles associated with compliance, regulatory inspections and audits in global environment
Regulations governing Pharmaceutical Industry
What you can expect of 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.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
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, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.