Global Pharmacovigilance Senior Scientist

2 weeks ago

Washington DC, United States Amgen Full time

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.

Global Safety Senior Manager, Pharmacovigilance Senior ScientistLive

What you will do

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

  • Signal detection, evaluation, and management- Perform data analysis to evaluate safety signals and write up analysis results
  • Directs the planning, preparation, writing and review of portions of aggregate reports
  • Coordinate and direct liaison for activities with affiliates and other internal Amgen partner regarding products
  • 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
  • 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
  • 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
  • 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 responsibilityWin

    What we expect of you

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

    Doctorate degree and 2 years of Pharmacovigilance and/or drug/product safety experience

    OR

    Masters degree and 4 years of Pharmacovigilance and/or drug/product safety experience

    OR

    Bachelors degree and 6 years of Pharmacovigilance and/or drug/product safety experience

    OR

    Associates degree and 10 years of Pharmacovigilance and/or drug/product safety experience

    OR

    High school diploma / GED and 12 years of Pharmacovigilance and/or drug/product safety experiencePreferred Qualifications:

  • BS, RN or PharmD degree
4+ years Pharmacovigilance experience in the Pharmaceutical or Biotech industry4+ years benefit risk evaluations, therapeutic area safety in oncologyBroad PV knowledge with expertise within defined subject areaApplied knowledge and broad understanding of multiple subject areasExperience in signal detection, evaluation, aggregate data analysis, and interpretationExperience with document writing and source document reviewAbility to convey complex, scientific data in an understandable wayGood clinical and scientific judgmentKnowledge of Application of medical concepts and terminologyThrive

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 planStock-based long-term incentivesAward-winning time-off plans and bi-annual company-wide shutdownsFlexible work models, including remote work arrangements, where possibleApply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.careers.amgen.comApplication deadline

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 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.

  • Global Pharmacovigilance

    2 months ago

    Washington, Washington, D.C., United States Amgen Full time

    Job DescriptionHOW MIGHT YOU DEFY IMAGINATION?If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and...

  • Senior Vice President, Pharmacovigilance

    1 week ago

    Washington, United States Cornerstone Search Group Full time

    Position OverviewA dynamic Biotech organization is seeking a Vice President of Drug Safety to spearhead and establish a comprehensive Drug Safety/Risk Management/Pharmacovigilance division, in anticipation of several global product launches in the coming years. Additionally, you will oversee Drug Safety initiatives for an existing marketed product. This role...

  • Senior Vice President, Pharmacovigilance

    1 week ago

    Washington, United States Cornerstone Search Group Full time

    A dynamic Biotech organization is seeking a Vice President of Drug Safety to spearhead and develop a comprehensive Drug Safety/Risk Management/Pharmacovigilance division, in light of several anticipated global product launches in the coming years. Additionally, you will oversee Drug Safety initiatives for an existing marketed product. This role offers the...

  • Senior Vice President, Pharmacovigilance

    2 weeks ago

    Washington, United States Cornerstone Search Group Full time

    OverviewA prominent Biotech organization is seeking a Vice President of Drug Safety to spearhead and establish a comprehensive Drug Safety/Risk Management/Pharmacovigilance division, in anticipation of several global product launches in the coming years. Additionally, you will oversee Drug Safety initiatives for an existing marketed product. This role...

  • Senior Vice President, Pharmacovigilance

    2 weeks ago

    Washington, United States Cornerstone Search Group Full time

    Position OverviewA dynamic and expanding Biotech organization is seeking a Vice President of Drug Safety to spearhead and develop a comprehensive Drug Safety/Risk Management/Pharmacovigilance division, in anticipation of several global product launches in the near future. This role also encompasses overseeing Drug Safety initiatives for an existing marketed...

  • Senior Vice President, Pharmacovigilance

    1 week ago

    Washington, United States Cornerstone Search Group Full time

    OverviewA prominent Biotech organization is seeking a Vice President of Drug Safety to spearhead and develop a comprehensive Drug Safety/Risk Management/Pharmacovigilance division, in anticipation of several global product launches in the near future. This role also encompasses overseeing Drug Safety initiatives for an existing marketed product. The position...

  • Senior Vice President, Pharmacovigilance

    1 week ago

    Washington, United States Cornerstone Search Group Full time

    OverviewA prominent Biotech organization is seeking a Vice President of Drug Safety to spearhead and establish a comprehensive Drug Safety/Risk Management/Pharmacovigilance division, in light of several anticipated global product launches in the coming years. Additionally, you will oversee Drug Safety initiatives for an existing marketed product. This role...

  • Senior Vice President, Pharmacovigilance and Risk Management

    2 weeks ago

    Washington, United States Cornerstone Search Group Full time

    Position Overview:A dynamic Biotech organization is seeking a Senior Vice President of Pharmacovigilance to spearhead and develop a comprehensive Drug Safety and Risk Management division, anticipating several global product launches in the coming years. Key Responsibilities:As the leader of the Drug Safety department, you will have overall accountability for...

  • Senior Vice President, Pharmacovigilance and Risk Management

    2 weeks ago

    Washington, United States Cornerstone Search Group Full time

    Position Overview:A dynamic Biotech organization is seeking a Senior Vice President of Pharmacovigilance to spearhead and develop a comprehensive Drug Safety and Risk Management division, anticipating several global product launches in the near future. Key Responsibilities:As the leader of the Drug Safety initiatives for an existing marketed product, you...

  • Principal Technical Product Owner

    3 weeks ago

    Washington D.C., United States Amgen Full time

    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...

  • Principal Technical Product Owner

    3 weeks ago

    Washington D.C., United States Amgen Full time

    HOW MIGHT YOU DEFY IMAGINATION? If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering...

  • Senior Data Scientist

    1 day ago

    Washington, United States Walmart Full time

    About the RoleWe are seeking a highly skilled Senior Data Scientist to join our Global Tech team at Walmart. As a key member of our international data science community, you will play a critical role in driving business growth and innovation through data-driven insights.Key ResponsibilitiesDevelop and deploy advanced statistical models, machine learning...

  • Senior Scientist

    3 months ago

    Washington D.C., United States Amgen Full time

    HOW MIGHT YOU DEFY IMAGINATION?Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology...

  • Senior Medical Scientist

    3 months ago

    Washington D.C., United States Amgen Full time

    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...

  • Global Safety Manager

    2 months ago

    Washington, Washington, D.C., United States Amgen Full time

    HOW MIGHT YOU DEFY IMAGINATION?You've worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world's leading...

  • Senior Director, Global Program Management

    3 weeks ago

    Washington D.C., United States Amgen Full time

    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...

  • Global Safety Manager

    2 months ago

    Washington, Washington, D.C., United States Amgen Full time

    HOW MIGHT YOU DEFY IMAGINATION?Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology...

  • Global Category Senior Manager

    1 month ago

    Washington D.C., United States Amgen Full time

    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...

  • Vice President, Global Drug Safety and Risk Management Leader

    1 day ago

    Washington, United States Cornerstone Search Group Full time

    About the RoleWe are seeking an experienced Vice President to lead our Drug Safety and Risk Management function, driving strategic initiatives and building a high-performing team. As a key member of our leadership team, you will report directly to the Chief Medical Officer and collaborate closely with cross-functional teams to ensure the success of our...

  • Global Feasibility Senior Manager

    3 months ago

    Washington D.C., United States Amgen Full time

    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...