7 days old

Senior Manager Global Safety - Inflammation

Amgen
Berkeley Heights, NJ 07922
  • Job Code
    117942299
Amgen

Job ID: R-91709
Location: Berkeley Heights, NJ, US 07922

Amgen is seeking a Sr. Manager Global Safety for our location in Berkeley Heights, New Jersey.

The Global Safety Therapeutic Areas serve as the safety experts for all Amgen products globally and are accountable for the safety strategy and major safety deliverables for each Amgen product from early clinical development to marketed products. Leaders in the therapeutic area safety teams are accountable for the staff management and resource allocations in Global Patient Safety and support GPS in the establishment of a highly effective global safety organization in full compliance to worldwide regulations.

Key Responsibilities of the Sr. Manager Global Safety will include, but are not limited to, the following:

General Responsibilities
  • Provides support to Global Safety Officer/Lead Safety Physician (GSO/LSP) in activities relating to monitoring and management of Product's emerging safety profile
  • Leads the coordination of Safety Management Team (SAT)/Product Safety Review Meeting (PSRM) meetings, maintains roster, calendar, minutes/communication and preparation of materials, in support of the GSO/LSP
  • Develops materials (Slides, etc.) for Global Safety Team and provide input into recommended safety actions
  • Oversees the adjudication and analysis of signal detection outputs, quality assurance of synthesized key safety information; Development and continuous improvement of signal detection evaluation and tracking tool
  • Leads ad hoc regulatory safety requests by obtaining data from the clinical trial and global safety database as well as literature, and assist the GSO/LSP in determining the impact of the safety issue on the product's benefit/risk profile
  • Provides support to GSO/LSP for Product Quality issue and inquiries from external department (e.g. Legal, clinical, regulatory affairs, etc.)


Trial Safety Support
  • Oversees the operational execution of all safety-related clinical trial activities
  • Leads the strategy for surveillance activities, signal assessment, and regulatory safety requests for multiple compounds and/or key registrational clinical trials (in development or investigator-initiated)
  • Oversees SAE reconciliation
  • Oversees study-level activities (as needed): generation of Case Management Work aids, safety sections of the protocols & Clinical Study Reports, risk/benefit assessment for EU CTAs, protocol/CRF review, ICF
  • Oversees the development of trial related documents
  • Leads review of study-specific Statistical Analysis Plan (SAP) and statistical outputs (e.g. tables, listings & graphs [TLGs]), and contribute to the safety strategy and key safety messages for the CSR


Compound Level Safety Support
  • Authors or oversees development of content for safety sections of documents such as Investigator's Brochures, Aggregate Safety Reports (PSUR/DSUR), Annual Reports, Standard Risk Language for ICFs, Company Core Data Sheet and Risk Management Plans
  • Assists the GSO/LSP with the management of the product's benefit/risk profile


Post-marketing Support
  • Participation in the signal detection strategy
  • Leads Safety Topic Review
  • Authors or oversees development of content for safety sections of documents such as aggregate safety reports (PSUR/DSUR)
  • Leads literature review and QC


Departmental Activities
  • Liaises with Patient Safety and Labeling staff and maintain an effective and collaborative product safety team


Governance
  • Participate and/or provide input to materials and strategies at meetings including but not limited to:
    • SAT - Safety Team
    • DMC - Data Monitoring Committees - internal or external
    • Product Development Team
    • Clinical Study Team
    • Risk Management


Basic Qualifications

Doctorate degree and 2 years of relevant pharmaceutical industry experience in Safety or Clinical Development

OR

Master's degree and 6 years of relevant pharmaceutical industry experience in Safety or Clinical Development

OR

Bachelor's degree and 8 years of relevant pharmaceutical industry experience in Safety or Clinical Development

OR

Associates degree and 10 years of relevant pharmaceutical industry experience in Safety or Clinical Development

OR

High school diploma / GED and 12 years of relevant pharmaceutical industry experience in Safety or Clinical Development

Preferred Qualifications
  • Advanced scientific degree (e.g., BS, MS, PharmD, PhD) or other degree with the equivalent combination of relevant education and professional experience
  • At least 8-10 years of relevant pharmaceutical industry experience. Previous experience in Safety or Clinical Development or Operations is required.
  • 4 years of Drug Safety Experience
  • 2 years management experience


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.

Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

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.

PI117942299

<b>Amgen</b><br/><br/><b>Job ID: </b>R-91709<br/><b>Location: </b>Berkeley Heights, NJ, US 07922<br/><br/>Amgen is seeking a Sr. Manager Global Safety for our location in Berkeley Heights, New Jersey. <br><br>The Global Safety Therapeutic Areas serve as the safety experts for all Amgen products globally and are accountable for the safety strategy and major safety deliverables for each Amgen product from early clinical development to marketed products. Leaders in the therapeutic area safety teams are accountable for the staff management and resource allocations in Global Patient Safety and support GPS in the establishment of a highly effective global safety organization in full compliance to worldwide regulations.<br><br>Key Responsibilities of the Sr. Manager Global Safety will include, but are not limited to, the following:<br><br> General Responsibilities <br><ul><li>Provides support to Global Safety Officer/Lead Safety Physician (GSO/LSP) in activities relating to monitoring and management of Product's emerging safety profile</li><li>Leads the coordination of Safety Management Team (SAT)/Product Safety Review Meeting (PSRM) meetings, maintains roster, calendar, minutes/communication and preparation of materials, in support of the GSO/LSP</li><li>Develops materials (Slides, etc.) for Global Safety Team and provide input into recommended safety actions</li><li>Oversees the adjudication and analysis of signal detection outputs, quality assurance of synthesized key safety information; Development and continuous improvement of signal detection evaluation and tracking tool</li><li>Leads ad hoc regulatory safety requests by obtaining data from the clinical trial and global safety database as well as literature, and assist the GSO/LSP in determining the impact of the safety issue on the product's benefit/risk profile</li><li>Provides support to GSO/LSP for Product Quality issue and inquiries from external department (e.g. Legal, clinical, regulatory affairs, etc.)</li></ul><br><br>Trial Safety Support <br><ul><li>Oversees the operational execution of all safety-related clinical trial activities</li><li>Leads the strategy for surveillance activities, signal assessment, and regulatory safety requests for multiple compounds and/or key registrational clinical trials (in development or investigator-initiated)</li><li>Oversees SAE reconciliation</li><li>Oversees study-level activities (as needed): generation of Case Management Work aids, safety sections of the protocols & Clinical Study Reports, risk/benefit assessment for EU CTAs, protocol/CRF review, ICF</li><li>Oversees the development of trial related documents</li><li>Leads review of study-specific Statistical Analysis Plan (SAP) and statistical outputs (e.g. tables, listings & graphs [TLGs]), and contribute to the safety strategy and key safety messages for the CSR</li></ul><br><br>Compound Level Safety Support <br><ul><li>Authors or oversees development of content for safety sections of documents such as Investigator's Brochures, Aggregate Safety Reports (PSUR/DSUR), Annual Reports, Standard Risk Language for ICFs, Company Core Data Sheet and Risk Management Plans</li><li>Assists the GSO/LSP with the management of the product's benefit/risk profile</li></ul><br><br>Post-marketing Support <br><ul><li>Participation in the signal detection strategy</li><li>Leads Safety Topic Review</li><li>Authors or oversees development of content for safety sections of documents such as aggregate safety reports (PSUR/DSUR)</li><li>Leads literature review and QC</li></ul><br><br>Departmental Activities <br><ul><li>Liaises with Patient Safety and Labeling staff and maintain an effective and collaborative product safety team</li></ul><br><br>Governance <br><ul><li>Participate and/or provide input to materials and strategies at meetings including but not limited to:<ul><li>SAT - Safety Team</li><li>DMC - Data Monitoring Committees - internal or external</li><li>Product Development Team</li><li>Clinical Study Team</li><li>Risk Management</li></ul></li></ul><br><br>Basic Qualifications <br><br>Doctorate degree and 2 years of relevant pharmaceutical industry experience in Safety or Clinical Development<br><br>OR<br><br>Master's degree and 6 years of relevant pharmaceutical industry experience in Safety or Clinical Development<br><br>OR<br><br>Bachelor's degree and 8 years of relevant pharmaceutical industry experience in Safety or Clinical Development<br><br>OR<br><br>Associates degree and 10 years of relevant pharmaceutical industry experience in Safety or Clinical Development<br><br>OR<br><br>High school diploma / GED and 12 years of relevant pharmaceutical industry experience in Safety or Clinical Development<br><br>Preferred Qualifications <br><ul><li>Advanced scientific degree (e.g., BS, MS, PharmD, PhD) or other degree with the equivalent combination of relevant education and professional experience</li><li>At least 8-10 years of relevant pharmaceutical industry experience. Previous experience in Safety or Clinical Development or Operations is required.</li><li>4 years of Drug Safety Experience</li><li>2 years management experience</li></ul><br><br>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.<br><br>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.<br><br>Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.<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/W7MB8KFnEZR4iM7jTpBPL"> <p>PI117942299</p>

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Posted: 2020-02-11 Expires: 2020-03-13

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Senior Manager Global Safety - Inflammation

Amgen
Berkeley Heights, NJ 07922

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