Global Safety Officer (GSO), Global Safety Medical Director - Obesity, US - Remote

Amgen • Thousand Oaks, CA

91d • $243,245 - $319,267

About The Position

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 them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Requirements

• MD or DO degree from an accredited medical school
• Completion of an accredited medical or surgical residency
• Clinical experience in either an accredited academic setting or private practice (including hospital based) setting

Nice To Haves

• 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

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

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
• Flexible spending accounts
• A discretionary annual bonus program
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models, including remote and hybrid work arrangements

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees