Pharmacovigilance Scientist, 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.

Pharmacovigilance Scientist, Senior Manager

What you will do

Lets do this. Lets change the world. The Global Safety Therapeutic Areas serve as the safety experts for all Amgen products globally and are accountable for the safety strategy and major safety deliverables for each Amgen product. Leaders in the therapeutic area safety teams are accountable for the staff management and resource allocations in Global Patient Safety and support GPS in the establishment of a highly effective global safety organization in full compliance to worldwide regulations.

In this vital role you will work with the Therapeutic Safety Teams for safety assessment activities for medical/scientific operations and provide scientific and compliance expertise as needed to GPS.

• Directs the planning, preparation, writing and review of portions of aggregate reports
• Organize and direct liaison for activities with affiliates and other internal Amgen partner regarding products
• Supports and provides oversight to staff with regards to safety in clinical trials

Review and provide input and support on study protocols, statistical analysis plans and other clinical study-related documents.

• Review of AEs/SAEs from clinical trials as needed
• 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
• Participate in study team meetings as requested or needed
• Signal detection, evaluation, and management- Perform data analysis to evaluate safety signals and write up analysis results
• Documents work as required in the safety information management system
• Author Safety Assessment Reports and other safety documents and regulatory responses in collaboration with the GSO
• Search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection
• Prepare presentation of the Global Safety Teams recommendations on safety issues to the cross-functional decision-making body

Assist GSO in the development of risk management strategy and activities:

• Provides contents for risk management plans
• Develop or update strategy and content for regional risk management plans
• Assist GSOs with aspects of 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 in developing a strategy for safety-related regulatory activities
• Provide safety contents for filings

Inspection Readiness:

• 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
• Processes and regulations for pharmacovigilance and risk management
• Drug development and lifecycle management
• Safety data capture in clinical development and post-market settings
• Safety database structure and conventions
• MedDRA and other dictionaries used in pharmacovigilance
• Methods of qualitative and quantitative safety data analysis
• Inter-relationship across various pharmacovigilance processes and documents, including reference safety information and product labeling

Pharmacovigilance skills-intermediate knowledge of the following:

• Signal detection, evaluation and management
• Aggregate data analysis, interpretation and synthesis
• Application of medical concepts and terminology
• Document writing and source document review
• Writing Risk Management Plans
• Ability to convey complex, scientific data in an understandable way
• Ability to analyze and interpret complex safety data
• Intermediate skills in application of statistical and epidemiological methods to pharmacovigilance

Biomedical Literature-intermediate skills:

• Literature Surveillance: source document review knowledge and skills
• Literature search, evaluation and assessment skills-ability to search literature databases to identify safety literature for signal evaluation and assessment, interpretation and synthesis skills

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek has these qualifications.

Doctorate degree and 2 years of safety/ pharmacovigilance related experience

Or

Masters degree and 6 years of safety/ pharmacovigilance related experience

Or

Bachelors degree and 8 years of safety/ pharmacovigilance related experience

Or

Associates degree and 10 years of safety/ pharmacovigilance related experience

Or

High school diploma / GED and 12 years of safety/ pharmacovigilance related experience

And

2 years of managerial experience directly managing people and or leadership experience leading teams, project, programs or directing the allocation of resources

What you can expect of us

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

for a career that defies imagination

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

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 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.