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

Amgen • Thousand Oaks, CA

2d • Remote

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. Global Safety Officer (GSO), Global Safety Medical Director - Obesity, US - Remote What you will do Let’s do this. Let’s change the world. 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). 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.

Requirements

• MD or DO degree from an accredited medical school AND
• Completion of an accredited medical or surgical residency OR
• 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/Cardiovascular 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, 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

What This Job Offers

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