Safety Sciences Lead

The Global Safety Therapeutic Areas serve as the safety experts for all Amgen products globally and are accountable for the robust safety strategy and deliverables for each Amgen product.

The group collaboratively drive excellence in patient safety by leading signal detection, management activities, and risk management practices, including Risk Evaluation and Mitigation Strategies (REMS). Through the definition and implementation of innovative policies, research initiatives, and best practices in safety science, the teams ensure comprehensive benefit-risk assessments, effective safety communications, and adherence to quality processes supported by measurable metrics.

Leaders in the therapeutic area safety teams are accountable for the staff management and resource allocations in Global Patient Safety and support GPS in the establishment of a highly effective global safety organization in full compliance with worldwide regulations.

Lets do this. Lets change the world. In this vital role you will oversee all signal management activities and staff in the Safety Sciences Team at the India site, working closely with the global teams while ensuring compliance with global regulations and company standards. This role requires a strong leadership attribute with a deep understanding of drug safety and pharmacovigilance, signal detection and management, safety data analyses, risk management and people leadership/ management, along with experience in innovation and technology.

This staff member will provide leadership to the Safety Sciences Team, consisting of staff based in India working across multiple therapeutic areas and signal management, while reporting into the GPS AIN Lead.

• Provide direction, strategy and leadership for signal detection and management activities at the India site
• Provide managerial leadership to the safety sciences team allowing appropriate prioritization of resources to achieve GPS goals.
• Regular communication with the global team to discuss product and/or process issues.
• Recruit and retain talented safety professionals. Provide coaching, mentoring, and development of staff
• Ensure staff are compliant with Amgen corporate and departmental training
• Disseminate relevant information to teams as appropriate
• Ensures smooth and collaborative interactions with all other Safety groups
• Provides relevant input on technical processes in the department and contributes to continuous improvement initiatives across GPS
• Accountable for delivery against goals assigned to group
• Participate in budget and headcount planning
• Establish effective, collaborative interfaces with partners outside of GPS e.g. tech to ensure GPS needs are being met with respect to signal management
• Lead or contribute to cross-functional initiatives aimed to improve pharmacovigilance capabilities related to signal management

We are all different, yet we all use our unique contributions to serve patients.

Basic Qualifications:

• 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