Pharmacovigilance Senior Manager
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.
Pharmacovigilance Senior ManagerLive
What you will do
Lets do this. Lets change the world. In this vital role you will have oversight of quality and data integrity standards for the collection of safety information to meet internal partner needs and Regulatory reporting obligations.
- Oversight of the data harmonization between clinical trial databases (CTDB) and Amgen global safety database (AGSDB) in accordance with process documentation.
- Oversight of the creation and maintenance of medically relevant dictionary coding search strategies, e.g. SMQ and AMQs used for extraction of safety data from the clinical and safety databases for the Global Patient Safety product teams and Biostats.
- Maintain compliance with global regulations and drive continual improvement of processes within remit.
- Provide Subject Matter Expertise on standard medical dictionaries and other relevant terminologies
- Ensure all current medical terminology dictionaries are maintained, relevant data are up-versioned and clients trained on use
- Proactively partner with cross-functional stakeholders in GPS&P, GDO, GBS and other relevant functions to develop consistent coding strategies and services
- Provide input into the development of information and data management strategies
- Manage and oversee the routine activities needed to support accurate and consistent transfer of safety data between the clinical and safety databases during study execution
- Manage individual and group projects
- Manage the follow up on coding and/or safety data alignment activities necessary to support clinical database snapshots or locks during study closeout
- Participate in the creation of standard process documentation and training materials (eg. SOPs, MANs Coding Guidelines) and ensure stakeholders are trained
- Lead reconciliation team and budget
- Manage the definition, collection and assessment of coding Metrics
- 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
- Perform other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by his/her supervisor
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The diligent professional we seek is insightful with these qualifications.
Education & Experience (Basic)
- Doctorate degree OR
- Masters degree and 3 years of directly related experience OR
- Bachelors degree and 5 years of directly related experience OR
- Associates degree and 10 years of directly related experience Or
- High school diploma / GED and 12 years of directly related experience
Education & Experience (Preferred)
- Work experience in biotech/pharmaceutical industry
- Experience in safety databases, EDC systems and Coding systems
What you can expect of us
As we work to develop treatments that take care of others, so we work to care for our teammates professional and personal growth and well-being.
- Vast opportunities to learn and move up and across our global organization
- Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
- Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
for a career that defies imagination
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
careers.amgen.comEqual Opportunity Statement
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided a 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 an accommodation.
Join UsIf you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.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, or disability status.