Global Pharmacovigilance Safety, Senior Manager- Obesity

Amgen; Newark (NJ); Hybrid; USD 141,000 - 190,000; Full time

Benefits offered by this job

Retirement plan contributions

Medical, dental, vision coverage

Stock-based long-term incentives

Annual bonus program

Job summary

Amgen is a global biotechnology company focused on serving patients with serious illnesses. We are looking for a Global Pharmacovigilance Senior Manager to lead safety assessment activities, oversee AEs/SAEs review, and coordinate with affiliates and internal partners.

The role involves risk management planning, regulatory support, and inspection readiness. The position requires advanced degrees and substantial pharmacovigilance experience, including leadership and staff oversight.

Qualifications

• Doctorate degree with industry pharmacovigilance experience required.
• Masters with industry pharmacovigilance experience acceptable.
• Bachelor’s degree with 6+ years in pharmacovigilance would qualify.
• Associate’s degree with 10 years in pharmacovigilance acceptable.
• High school diploma with 12 years in pharmacovigilance acceptable.

Responsibilities

• Directs planning, preparation, writing and review of safety reports.
• Oversees liaison with affiliates and internal Amgen partners on products.
• Supports staff regarding safety in clinical trials and study docs.
• Reviews adverse events from trials and safety data tables.
• Develops safety-related data collection forms and participates in study teams.
• Signals detection, evaluation and management; analyzes safety data.

Skills

Leadership

Project management

Pharmacovigilance

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma

Job description

Career Category Safety Job Description 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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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.

Global Pharmacovigilance Senior Manager

What you will do Let’s do this. Let’s change the world. In this vital role you will work with the Therapeutic Safety Teams for safety assessment activities for medical/scientific operations.

• 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 to: 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 Team’s 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 to oversee 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

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The pharmacovigilance professional we seek is a leader with these qualifications.

• Doctorate degree and 2 years of industry pharmacovigilance experience
• Master’s degree and 4 years of industry pharmacovigilance experience
• Bachelor's degree and 6 years of industry pharmacovigilance experience
• Associate’s degree and 10 years of industry pharmacovigilance experience
• High school diploma/GED and 12 years of industry pharmacovigilance experience

Preferred Qualifications

• Bachelor’s in life science and Master’s and 6 years of related experience
• 2 years of managerial experience directly managing people or projects and/or mentoring experience
• Clinical or medical research experience
• 6 years of experience in the biotech/pharmaceutical setting

What you can expect of us

From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

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.

• A 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
• Flexible work models where possible

Salary Range 140,799.10USD -190,492.90 USD

Sponsorship

Sponsorship for this role is not guaranteed.

Equal Opportunity

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.

Company Information

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing 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. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen