Safety Sciences Lead

Join Amgen's mission to serve patients living with serious illnesses as a Safety Sciences Lead. Lead signal management activities and staff in the Safety Sciences Team at the India site, ensuring compliance with global regulations and company standards.

Requirements

• Medical degree and 6 years of directly related experience in global Pharmacovigilance for a biotechnology or pharmaceutical company in the clinical trial and post marketing environments.
• Minimum of 6 years of experience in global Pharmacovigilance for a biotechnology or pharmaceutical company in the clinical trial and post marketing environments.
• A minimum of 3 years of functional management experience overseeing PV staff
• A thorough understanding of the global PV regulatory environment with working knowledge of EU and US regulations, ICH guidelines, and GCP, a working understanding of drug safety databases, effective project management skills, a demonstrated ability to provide critical and timely insight, and analytical problem-solving skills with a broad perspective
• Leadership skills and the ability to oversee multiple projects simultaneously
• Able to successfully manage workload to timelines
• Able to respond and provide astute advice quickly to difficult scenarios or in response to tough questions
• Familiarity with basic project management tools
• Ability to negotiate a strategic position after taking feedback from multiple sources

Benefits

• Competitive and comprehensive Total Rewards Plans
• Health benefits
• Dental and vision benefits
• 401(k) and retirement savings plan
• Paid time off
• Life insurance
• Disability benefits
• Employee assistance program