24 days old

Sr Associate Pharmacovigilance Operations

Amgen
Thousand Oaks, CA 91360
  • Job Code
    116807976
Amgen

Job ID: R-84116
Location: Thousand Oaks, CA, US 91360

Amgen is seeking a Sr Assoc Pharmacovigilance Operations to join our team and work from Amgen's beautiful Thousand Oaks, CA campus. To learn more.....

The Sr. Associate PV Operations will be on task for the following:

•Support vendor oversight of all case intake and processing activities
•Case review
•Escalation of case level issues when necessary
•Support convention-related training delivery
•Manage queries on Intake, triage and data entry of ICSRs
•Reporting decision for submitting all expedited safety reports to FDA/EMA
•Ensuring that individual ICSRs are evaluated for reporting in compliance with regulations and contracts
•Reporting of ICSRs within time frames determined by regulations and contracts
•Support BP reconciliation as required by safety agreement
•Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
•Be the representative for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility
•Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by his/her supervisor

Basic Qualification:

Master's degree

OR

Bachelor's degree and 2 years of Pharmacovigilance or Regulatory experience

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.

Amgen focuses on areas of high unmet medical needs 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.

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.

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.

PI116807976

<b>Amgen</b><br/><br/><b>Job ID: </b>R-84116<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/>Amgen is seeking a <b>Sr Assoc Pharmacovigilance Operations</b> to join our team and work from Amgen's beautiful Thousand Oaks, CA campus. To learn more..... <br><br>The Sr. Associate PV Operations will be on task for the following:<br><br> Support vendor oversight of all case intake and processing activities <br> Case review <br> Escalation of case level issues when necessary <br> Support convention-related training delivery <br> Manage queries on Intake, triage and data entry of ICSRs <br> Reporting decision for submitting all expedited safety reports to FDA/EMA <br> Ensuring that individual ICSRs are evaluated for reporting in compliance with regulations and contracts <br> Reporting of ICSRs within time frames determined by regulations and contracts <br> Support BP reconciliation as required by safety agreement <br> Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness <br> Be the representative for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility <br> Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by his/her supervisor <br><br>Basic Qualification:<br><br>Master's degree<br><br>OR<br><br>Bachelor's degree and 2 years of Pharmacovigilance or Regulatory experience<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><b> Amgen </b> focuses on areas of high unmet medical needs 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. <br><br><b> Join Us </b><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>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/dapPBKUXokYmsJzgi1Pmz"> <p>PI116807976</p>

Categories

Posted: 2020-01-03 Expires: 2020-02-03

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

Sr Associate Pharmacovigilance Operations

Amgen
Thousand Oaks, CA 91360

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast