Global Pharmacovigilance (PV) Senior Scientist
Global Pharmacovigilance (PV) Senior Scientist
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$ 172515 - 172515
1 Vacancy
Job Description
Career Category
SafetyJob Description
Join Amgens Mission of Serving Patients
At Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.
Since 1980 weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology Inflammation General Medicine and Rare Disease we reach millions of patients each year. As a member of the Amgen team youll 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 awardwinning culture is collaborative innovative and science based. If you have a passion for challenges and the opportunities that lay within them youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Global Pharmacovigilance (PV) Senior Scientist
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 Global Patient Safety. Applicable tasks may vary by product(s) assigned.
Responsibilities
- Direct 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
- Support and provide 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 studyrelated documents
- Review of AE/SAEs from clinical trials as needed
- Review standard design of tables figures and listings for safety data from clinical studies
- Participate in development of safetyrelated 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
- Author safety assessment reports and other safety documents and regulatory responses in collaboration with the Global Safety Officer (GSO)
- Search and review adverse event data literature and other safetyrelevant data for the purpose of signal detection
- Prepare presentation of the Global Safety Teams recommendations on safety issues to the crossfunctional decisionmaking body
- Assist GSOs 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 safetyrelated regulatory activities
- Provide safety contents for filings
What we expect of you
We are all different yet we all use our unique contributions to serve patients. The professional we seek is a champion with these qualifications.
Basic Qualifications:
Doctorate degree and 2 years of pharmacovigilance experience
Or
Masters degree and 6 years of pharmacovigilance experience
Or
Bachelors degree and 8 years of pharmacovigilance experience
Or
Associates degree and 10 years of pharmacovigilance experience
Or
High school diploma / GED and 12 years of pharmacovigilance experience
Preferred Qualifications:
- BS or BA in Life Science with a MS and 6 years of related experience OR
- Bachelors degree and 8 years of related experience
And
- 2 years of managerial experience directly managing people and/or experience leading teams project programs or directing the allocation of resources
- Clinical/medical research experience
- 6 years of experience in a biotech/pharmaceutical setting
- Previous management and/or mentoring experience
What you can expect of us
As we work to develop treatments that take care of others we also work to care for your professional and personal growth and wellbeing. From our competitive benefits to our collaborative culture well 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.
In addition to the base salary Amgen offers a Total Rewards Plan based on eligibility comprising of 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 that may include:
- 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 salesbased incentive plan
- Stockbased longterm incentives
- Awardwinning timeoff plans
- Flexible work models including remote and hybrid work arrangements where possible
Apply now and make a lasting impact with the Amgen team.
In any materials you submit you may redact or remove ageidentifying information such as age date of birth or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Application 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.
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.
.Salary Range
148053.00 USD 172515.00 USDRequired Experience:
Exec
Employment Type
Full-Time
