Pharmacovigilance -Strategy and Digital Operations, 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.

Strategy and Digital Operations (PV), Senior Manager

What you will do

Lets do this. Lets change the world. In this vital role you will Responsible for:

• Oversight of automation activities for Global Patient (Pharmacovigilance) Safety systems
• Responsible for Business Oversight including the gathering and contributing to Business Requirements for automation and digital assets both initiated and ongoing
• Cross functional contribution for digital assets used by other functions
• Support and oversight of Training development and Change Management activities within Pharmacovigilance Operations
• To ensure Change Management activities within Pharmacovigilance Operations are tracked, monitored and documented appropriately (Oversight of Change Management activities for Pharmacovigilance Operations)
• Commitment to evaluating and implementing innovative digital solutions in Global Patient Safety(GPS), including automation, artificial intelligence, and large language models
• The ability to be self-motivated to understand current pharmacovigilance needs and how to address these needs within the technical ecosystems of the global enterprise
• Define and advance the product roadmap
• Champion innovation to elevate Amgen's Safety systems, empowering the business to improve its processes, efficiency, and effectiveness
• Help integrating cognitive capabilities to thoughtfully automate traditional, manual processes
• Champion for AI technologies by keeping up to date on new industry and emerging technologies in the Pharmacovigilance area
• Drive process and safety systems-related change through established governance forums
• Work collaboratively to define our short- and long-term roadmap to achieve efficiency and cost savings in line with Amgens digital vision
• Partner with cross-functional collaborators in GPS and other relevant functions to establishment data integrity to support data analytics and data reporting tools
• Contribute to the development and delivery of training related to safety system and tools
• Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
• Supports inspection and audit activities, and the co-ordination of global safety system outputs and written responses to findings as required within remit of role

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Strategy and Digital Operations (PV) professional we seek is a leader with these qualifications.

Basic Qualifications:

Doctorate degree and 2 years of experience

Or Masters degree and 6 years of experience

Or Bachelors degree and 8 years of experience

Or Associates degree and 10 years of experience

Or High school diploma / GED and 12 years of experience

And 2 years of experience leading projects, programs or directing the allocation of resources

Preferred Qualifications:

• In depth knowledge of safety systems as well as query and reporting tools
• Experience with Argus and/or ErisGlobal pharmacovigilance software
• Ability to effectively and succinctly communicate complex technical concepts and future enhancements aligned with driving efficiencies, compliance, and stellar quality across the pharmacovigilance toolkit
• Prior considerable experience managing implementation and steady state pharmacovigilance digital solutions with particular focus on Analytics and Reporting tools
• Proven leadership evaluating and implementing innovative digital solutions and the required change management elements for adoption of the technology
• Experience with digital project management and implementation
• Understanding of Oracle database, Oracle Developer, and standard programming languages
• Understanding of software development lifecycle and development standards, including validation methodology
• Understanding of global regulatory requirements for pharmacovigilance and safety reporting
• Understanding of Clinical Trial and Pharmacovigilance Processes
• Familiarity with statistical analysis and interpretation of aggregate safety data
• Personnel Management
• Organization, prioritization, planning and measurement of work delivery
• Ability to establish relationships and work cross-functionally
• Work independently; recognize and raise issues
• Pharmaceutical industry or health authority experience.
• Experience in supporting inspections or internal audits
• Written and oral communications, leadership and problem solving

As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.

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.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

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.