Job Title: Safety Sciences Lead
Location: Hyderabad, India
Work Location Type: On-site
Date Posted: February 4, 2025
Category: Research
Company Overview:
At Amgen, we are committed to serving patients living with serious illnesses. With over 40 years of experience in biotechnology, we focus on four therapeutic areas: Oncology, Inflammation, General Medicine, and Rare Diseases. Our award-winning culture is collaborative, innovative, and science-driven, empowering our employees to make a lasting impact on patients' lives and their own careers. Join us to be part of a mission that is transforming healthcare globally.
Job Description:
As the Safety Sciences Lead, you will be responsible for overseeing all signal management activities and leading the Safety Sciences Team at Amgen's India site. This critical role requires strong leadership, a deep understanding of drug safety and pharmacovigilance, signal detection and management, and safety data analysis. You will collaborate with global teams while ensuring compliance with global regulations and Amgen's standards.
You will provide leadership to the team, manage resource allocation, ensure compliance with training requirements, and contribute to continuous improvement initiatives within Global Patient Safety (GPS). This role also involves recruiting and mentoring staff, managing safety sciences activities, and driving cross-functional projects related to signal management.
Key Responsibilities:
Signal Detection and Management:
Lead signal detection and management activities at the India site.
Oversee the safety sciences team to ensure effective prioritization of resources and achievement of GPS goals.
Team Leadership and Development:
Manage and provide leadership to the safety sciences team, including staff recruitment, coaching, and development.
Ensure compliance with Amgen's corporate and departmental training programs.
Foster collaborative interactions within the safety groups and with external partners.
Global Collaboration:
Maintain regular communication with global teams to discuss product and process issues.
Ensure smooth collaboration with other Safety groups and stakeholders.
Continuous Improvement:
Contribute to technical process improvements and continuous improvement initiatives within GPS.
Lead or support cross-functional initiatives to enhance pharmacovigilance capabilities, particularly in signal management.
Resource Management:
Participate in budget and headcount planning to ensure effective resource management.
Provide strategic direction to ensure that safety data and signal management objectives are met.
Qualifications:
Basic Qualifications:
Medical degree with 6 years of directly related experience in global Pharmacovigilance within a biotechnology or pharmaceutical company (clinical trial and post-marketing environments).
Minimum of 6 years of experience in global Pharmacovigilance, with at least 3 years in a management role overseeing pharmacovigilance staff.
Comprehensive understanding of the global pharmacovigilance regulatory environment including EU, US regulations, ICH guidelines, and GCP.
Proficiency with drug safety databases and a solid understanding of project management.
Strong leadership skills with the ability to manage multiple projects and teams effectively.
Analytical problem-solving skills, with the ability to provide critical and timely insights.
Preferred Skills:
Familiarity with basic project management tools and the ability to negotiate strategic positions after gathering feedback.
Ability to provide quick and accurate responses to difficult scenarios or queries.
Shift Timings:
12:00 PM to 9:00 PM IST.
What Amgen Offers:
Amgen supports both your professional and personal growth, offering competitive benefits, a collaborative culture, and a commitment to your well-being. In addition to a competitive base salary, Amgen provides comprehensive total rewards plans that align with local industry standards.
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