BioSpace
Global Safety Officer (GSO), Global Safety Medical Director - Obesity, US - Remo
BioSpace, Washington, District of Columbia, us, 20022
Global Safety Officer (GSO), Global Safety Medical Director - Obesity, US - Remote
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Global Safety Officer (GSO), Global Safety Medical Director - Obesity, US - Remote
role at
BioSpace
In this vital role within the Global Patient Safety (GPS) organization, you will serve as the safety expert for the assigned development product(s), establishing the strategy, direction, and priorities of pharmacovigilance activities and will be accountable for the overall safety profile and all product-related decisions and deliverables for assigned products. You will also lead the Safety Analysis Team (SAT) and Global Safety Team (GST) and will be a core member of the Executive Safety Committee (ESC). In addition, you will participate as a member of the Evidence Generation Team and other relevant cross functional teams and will be assigned as delegate for the Therapeutic Area Head (TAH) and have management of Global Safety Physicians.
Responsibilities
Validate safety signals and lead safety signal assessments
Develop and maintain Core Safety Information (core data sheet, core risks in informed consent forms, etc.)
Prepare/review core and regional risk management plans including additional risk minimization measures
Prepare/review safety sections of periodic aggregate reports
Provide safety input to protocols, statistical analysis plans, and clinical study reports
Prepare/review safety sections of new drug applications and other regulatory filings
Serve as safety expert on Evidence Generation Team for assigned products
Inspection Readiness
Travel: Domestic and International travel ~10% may be required
Qualifications
Basic Qualifications MD or DO degree from an accredited medical school Completion of an accredited medical or surgical residency OR Clinical experience in either an accredited academic setting or private practice (including hospital based) setting
Preferred Qualifications Industry pharmacovigilance (PV) experience Product safety in the bio/pharmaceutical industry or regulatory agency Previous management and/or mentoring experience Board certification or equivalent training Expertise in Obesity therapeutic area Leadership experience within the safety profile of products assigned with cross-functional team members.
Compensation & Benefits Expected annual salary range for this role in the U.S. (excluding Puerto Rico) is $243,245 to $319,267. Additional benefits include health and welfare plans, financial plans, work/life balance, and career development opportunities. Total rewards plan is based on eligibility and includes discretionary annual bonus program, stock-based long-term incentives, and award-winning time-off plans.
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.
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 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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Global Safety Officer (GSO), Global Safety Medical Director - Obesity, US - Remote
role at
BioSpace
In this vital role within the Global Patient Safety (GPS) organization, you will serve as the safety expert for the assigned development product(s), establishing the strategy, direction, and priorities of pharmacovigilance activities and will be accountable for the overall safety profile and all product-related decisions and deliverables for assigned products. You will also lead the Safety Analysis Team (SAT) and Global Safety Team (GST) and will be a core member of the Executive Safety Committee (ESC). In addition, you will participate as a member of the Evidence Generation Team and other relevant cross functional teams and will be assigned as delegate for the Therapeutic Area Head (TAH) and have management of Global Safety Physicians.
Responsibilities
Validate safety signals and lead safety signal assessments
Develop and maintain Core Safety Information (core data sheet, core risks in informed consent forms, etc.)
Prepare/review core and regional risk management plans including additional risk minimization measures
Prepare/review safety sections of periodic aggregate reports
Provide safety input to protocols, statistical analysis plans, and clinical study reports
Prepare/review safety sections of new drug applications and other regulatory filings
Serve as safety expert on Evidence Generation Team for assigned products
Inspection Readiness
Travel: Domestic and International travel ~10% may be required
Qualifications
Basic Qualifications MD or DO degree from an accredited medical school Completion of an accredited medical or surgical residency OR Clinical experience in either an accredited academic setting or private practice (including hospital based) setting
Preferred Qualifications Industry pharmacovigilance (PV) experience Product safety in the bio/pharmaceutical industry or regulatory agency Previous management and/or mentoring experience Board certification or equivalent training Expertise in Obesity therapeutic area Leadership experience within the safety profile of products assigned with cross-functional team members.
Compensation & Benefits Expected annual salary range for this role in the U.S. (excluding Puerto Rico) is $243,245 to $319,267. Additional benefits include health and welfare plans, financial plans, work/life balance, and career development opportunities. Total rewards plan is based on eligibility and includes discretionary annual bonus program, stock-based long-term incentives, and award-winning time-off plans.
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.
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 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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