10 days old

Global Pharmacovigilance (PV) Senior Scientist

Amgen
Thousand Oaks, CA 91360
  • Job Code
    117895875
Amgen

Job ID: R-93283
Location: Thousand Oaks, CA, US 91360

Amgen is seeking a Global Pharmacovigilance (PV) Sr. Scientist to join our team and work from Amgen's beautiful Thousand Oaks, CA campus. To learn more about this position and Amgen:

The Global Pharmacovigilance (PV) Sr. Scientist works with the Therapeutic Safety Teams for safety assessment activities for medical/scientific operations.

The Global PV Sr. Scientist is responsible for the following:
  • 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 Adverse events and Serious Adverse Events (AEs/SAEs) from clinical trials.
  • 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.
  • Signal detection, evaluation, and management.
  • Perform data analysis to evaluate safety signals and write up analysis results.
  • Document work as required in the safety information management system.
  • 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 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 GSO's 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.
  • Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness.
  • Representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility.

Basic Qualifications:

Doctorate degree and 2 years of Pharmacovigilance experience
OR
Master's degree and 5 years of Pharmacovigilance experience
OR
Bachelor's degree and 7 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 in Life Science with 3 years drug safety experience, preferably in Pharmacovigilance experience
  • Experience in Signal detection, evaluation and management
  • Experience of Literature Surveillance: source document review knowledge and skills
  • Experience in aggregate data analysis, interpretation and synthesis
  • Good clinical and scientific judgment
  • Clinical and/or medical research experience
  • Understanding of methods of qualitative and quantitative safety data analysis

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

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 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.

Amgen provides a collaborative and creative culture in a company with a strong track record of innovation. Our culture encourages open dialogue and diverse views to land on the best solutions, and we help ensure our staff are equipped to excel today and tomorrow.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

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, or disability status.

PI117895875

<b>Amgen</b><br/><br/><b>Job ID: </b>R-93283<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/>Amgen is seeking a Global Pharmacovigilance (PV) Sr. Scientist to join our team and work from Amgen's beautiful Thousand Oaks, CA campus. To learn more about this position and Amgen: <br><br>The Global Pharmacovigilance (PV) Sr. Scientist works with the Therapeutic Safety Teams for safety assessment activities for medical/scientific operations.<br><br>The Global PV Sr. Scientist is responsible for the following:<br><ul><li>Directs the planning, preparation, writing and review of portions of aggregate reports.</li><li>Organize and direct liaison for activities with affiliates and other internal Amgen partner regarding products.</li><li>Supports and provides oversight to staff with regards to safety in clinical trials to:</li></ul><br>Review and provide input and support on study protocols, statistical analysis plans and other clinical study-related documents.<br><ul><li>Review of Adverse events and Serious Adverse Events (AEs/SAEs) from clinical trials.</li><li>Review standard design of tables, figures, and listings for safety data from clinical studies.</li><li>Participate in development of safety-related data collection forms for clinical studies</li><li>Participate in study team meetings.</li><li>Signal detection, evaluation, and management.</li><li>Perform data analysis to evaluate safety signals and write up analysis results.</li><li>Document work as required in the safety information management system.</li><li>Author Safety Assessment Reports and other safety documents and regulatory responses in collaboration with the Global Safety Officer (GSO).</li><li>Search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection.</li><li>Prepare presentation of the Global Safety Team's recommendations on safety issues to the cross-functional decision-making body.</li><li>Assist GSO in the development of risk management strategy and activities:<ul><li>Provides contents for risk management plans.</li><li>Develop or update strategy and content for regional risk management plans.</li><li>Assist GSO's to oversee risk minimization activities including tracking of activities as needed.</li><li>Evaluate risk minimization activity.</li><li>Prepare response to regulatory inquiries related to risk management plans under the guidance of GSO.</li></ul></li><li>Support activities related to new drug applications and other regulatory filings:<ul><li>Assist GSO in developing a strategy for safety-related regulatory activities.</li><li>Provide safety contents for filings.</li></ul></li><li>Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness.</li><li>Representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility.</li><li></li></ul><br><b>Basic Qualifications:</b><br><br>Doctorate degree and 2 years of Pharmacovigilance experience<br>OR<br>Master's degree and 5 years of Pharmacovigilance experience<br>OR<br>Bachelor's degree and 7 years of Pharmacovigilance experience<br>OR<br>Associates degree and 10 years of Pharmacovigilance experience<br>OR<br>High school diploma / GED and 12 years of Pharmacovigilance experience<br><br><b>Preferred Qualifications:</b><br><ul><li>BS in Life Science with 3 years drug safety experience, preferably in Pharmacovigilance experience</li><li>Experience in Signal detection, evaluation and management</li><li>Experience of Literature Surveillance: source document review knowledge and skills</li><li>Experience in aggregate data analysis, interpretation and synthesis</li><li>Good clinical and scientific judgment</li><li>Clinical and/or medical research experience</li><li>Understanding of methods of qualitative and quantitative safety data analysis</li></ul><br>If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.<br><br><b>Amgen</b>, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.<br><br>As an organization dedicated to improving the quality of life for people around the world,<br><br><b>Amgen</b> fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.<br><br><b>Amgen </b>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.<br><br><b>Amgen</b> focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A<br><br>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.<br><br><b> Amgen </b> provides a collaborative and creative culture in a company with a strong track record of innovation. Our culture encourages open dialogue and diverse views to land on the best solutions, and we help ensure our staff are equipped to excel today and tomorrow. <br><br>Join Us <br> <br> If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. <br> <br> Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. <br> <br> 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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. <br> <br> 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, or disability status.<br/><br/> <img src="https://analytics.click2apply.net/v/7eOadLfndM5nfZ1NF7Y5y"> <p>PI117895875</p>

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Posted: 2020-02-08 Expires: 2020-03-10

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Global Pharmacovigilance (PV) Senior Scientist

Amgen
Thousand Oaks, CA 91360

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