Patient Safety Agreement (compliance/paralegal) Management - Manager
- Job Reference: 138382586-2
- Date Posted: 14 February 2020
- Recruiter: Amgen
- Location: Thousand Oaks, California
- Salary: On Application
- Sector: Paralegals
- Job Type: Permanent
Amgen is seeking a Patient Safety Agreement Manager to join our team and work from Amgen's beautiful Thousand Oaks, CA campus. To learn more about this position:
The Patient Safety Agreement Management team act as a hub for the safety and regulatory aspects of business partnerships and strategic alliances, from inception through implementation and maintenance. The team ensures that safety agreements for our business partnerships and other commercial alliances are robustly documented and managed, implemented efficiently and effectively, in line with operational objectives and capabilities.
The Patient Safety Agreement Manager reports to Director, Patient Safety Agreement Management and will provide operational support for day to day PSAM activities.
- Supports business partner safety agreement monitoring
- Assists in triaging and handling requests from business partners and internal stakeholders
- Provides project management support for operational meetings (OMTs) with business partners
- Supports business partner pharmacovigilance audits as required
- Supports development of process related documentation to ensure compliance
- Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by his/her supervisor
- Undertakes activities delegated by the EU QPPV as detailed in the PV System Master File and maintains a state of inspection readiness
Knowledge and Skills
- Good attention to detail
- Good organization and time management skills
- Good written and oral communication skills
- Capable of creative problem solving
- Ability to envision and implement business process solutions
- Strong collaboration skills with good customer focus
- Demonstrates flexibility, adaptability and sense of accountability
- Demonstrated ability to build relationships and work cross-functionally
- Ability to successfully prioritize a diverse workload to meet deadlines
- Knowledge of Regulatory and Safety functional activities
Master's degree and 2 years of directly related experience
Bachelor's degree and 4 years of directly related experience
Associate's degree and 10 years of directly related experience
High school diploma / GED and 12 years of directly related experience
Masters degree and 4 years or more experience
Experience working as a paralegal/compliance
Experience working in pharmacovigilance or in a project management role
Amgen provides a collaborative and creative culture in a company with a strong track record of innovation. Our culture encourages open dialogue and diverse views to land on the best solutions, and we help ensure our staff are equipped to excel today and tomorrow.
Amgen focuses on areas of high unmet medical needs and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
If 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.