BioSpace
Global Safety Senior Manager, Hematology Oncology - Remote
BioSpace, Washington, District of Columbia, us, 20022
Global Safety Senior Manager, Hematology Oncology - Remote
Join to apply for the Global Safety Senior Manager, Hematology Oncology - Remote role at BioSpace.
Overview Join Amgen's mission of serving patients. At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission to serve patients living with serious illnesses drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s 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, you’ll 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 award‑winning culture is collaborative, innovative, and science‑based. If you have a passion for challenges and the opportunities that lie within, you’ll thrive as part of the Amgen team.
Responsibilities
Review adverse event data, literature, and other safety‑relevant data for the purpose of signal detection.
Perform data analysis to evaluate safety signals and write up analysis results.
Author safety assessment reports as well as other safety documents and regulatory responses in collaboration with the Global Safety Officer (GSO).
Prepare and present the Global Safety Teams recommendations on safety issues to cross‑functional decision‑making bodies.
Author and review portions of periodic aggregate safety reports (e.g., PBRERs, DSURs).
Support clinical trial‑related activities: provide support and oversight to staff with regards to safety in clinical trials; review and provide input and support on clinical trial‑related documents (e.g., study protocols, statistical analysis plans, safety‑related data collection forms, and the design of tables, figures, and listings for clinical trial safety data); review of adverse events or serious adverse events from clinical trials; and participate in study team meetings.
Assist the GSO in the development of risk management strategies and activities: provide contents for risk management plans (RMPs); develop or update strategy and content for regional RMPs; assist the GSO in coordinating risk minimization activities including tracking of activities; evaluate risk minimization activities; and prepare responses to regulatory inquiries related to RMPs under the guidance of the GSO.
Support activities related to new drug applications and other regulatory filings: assist the GSO in developing a strategy for safety‑related regulatory activities; and provide safety contents for filings.
Document work in the safety information management system.
Organize and act as a direct liaison for safety activities with affiliates and other internal Amgen partners.
Undertake activities delegated by the Qualified Person for PV as detailed in the PV system master file and maintain a state of inspection readiness.
Represent and be the point of contact for health authority inspections and internal process audits within the remit of the role.
Basic Qualifications
Doctorate degree and 2 years of directly related experience
Masters degree and 4 years of directly related experience
Bachelors degree and 6 years of directly related experience
Associates degree and 10 years of directly related experience
High school diploma / GED and 12 years of directly related experience
Preferred Qualifications
RN, PharmD, or PA
6 years of experience in a biotech/pharmaceutical setting
Previous management and/or mentoring experience
Experience in signal detection, evaluation and management
Experience in aggregate data analysis, interpretation and synthesis
Experience in authoring periodic aggregate safety reports (e.g., PBRERs, DSURs) and RMPs
Clinical and/or medical research experience
Knowledge of ICH guidelines, safety systems (e.g., ARISg and Argus) and MedDRA
Benefits
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 sales‑based incentive plan
Stock‑based long‑term incentives
Award‑winning time‑off plans
Flexible work models, including remote and hybrid work arrangements, where possible
Application Information 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.
Equal Opportunity Employer 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.
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Overview Join Amgen's mission of serving patients. At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission to serve patients living with serious illnesses drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s 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, you’ll 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 award‑winning culture is collaborative, innovative, and science‑based. If you have a passion for challenges and the opportunities that lie within, you’ll thrive as part of the Amgen team.
Responsibilities
Review adverse event data, literature, and other safety‑relevant data for the purpose of signal detection.
Perform data analysis to evaluate safety signals and write up analysis results.
Author safety assessment reports as well as other safety documents and regulatory responses in collaboration with the Global Safety Officer (GSO).
Prepare and present the Global Safety Teams recommendations on safety issues to cross‑functional decision‑making bodies.
Author and review portions of periodic aggregate safety reports (e.g., PBRERs, DSURs).
Support clinical trial‑related activities: provide support and oversight to staff with regards to safety in clinical trials; review and provide input and support on clinical trial‑related documents (e.g., study protocols, statistical analysis plans, safety‑related data collection forms, and the design of tables, figures, and listings for clinical trial safety data); review of adverse events or serious adverse events from clinical trials; and participate in study team meetings.
Assist the GSO in the development of risk management strategies and activities: provide contents for risk management plans (RMPs); develop or update strategy and content for regional RMPs; assist the GSO in coordinating risk minimization activities including tracking of activities; evaluate risk minimization activities; and prepare responses to regulatory inquiries related to RMPs under the guidance of the GSO.
Support activities related to new drug applications and other regulatory filings: assist the GSO in developing a strategy for safety‑related regulatory activities; and provide safety contents for filings.
Document work in the safety information management system.
Organize and act as a direct liaison for safety activities with affiliates and other internal Amgen partners.
Undertake activities delegated by the Qualified Person for PV as detailed in the PV system master file and maintain a state of inspection readiness.
Represent and be the point of contact for health authority inspections and internal process audits within the remit of the role.
Basic Qualifications
Doctorate degree and 2 years of directly related experience
Masters degree and 4 years of directly related experience
Bachelors degree and 6 years of directly related experience
Associates degree and 10 years of directly related experience
High school diploma / GED and 12 years of directly related experience
Preferred Qualifications
RN, PharmD, or PA
6 years of experience in a biotech/pharmaceutical setting
Previous management and/or mentoring experience
Experience in signal detection, evaluation and management
Experience in aggregate data analysis, interpretation and synthesis
Experience in authoring periodic aggregate safety reports (e.g., PBRERs, DSURs) and RMPs
Clinical and/or medical research experience
Knowledge of ICH guidelines, safety systems (e.g., ARISg and Argus) and MedDRA
Benefits
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 sales‑based incentive plan
Stock‑based long‑term incentives
Award‑winning time‑off plans
Flexible work models, including remote and hybrid work arrangements, where possible
Application Information 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.
Equal Opportunity Employer 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.
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