Eli Lilly Support Member Jobs
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Industry: Private
Employment Type: Full Time
Work Hours: 8
Salary: £35 – £45Hour
Location: United Kingdom
Company: Eli Lilly
Description:
Eli Lilly Support Member Jobs
Job Purpose:
The purpose of the UK/IE Pharmacovigilance (PhV) Leader is to manage the UK/IE affiliate PhV operations, ensuring compliance to applicable company requirements and pharmacovigilance regulations. The UK/IE PhV Leader is responsible for meeting patient safety deliverables within the region, and will serve as liaison to the Qualified Person for Pharmacovigilance (QPPV) Group, industry bodies and national competent authorities (Medicines Healthcare and Products Agency (MHRA) and Health Products Regulatory Authority (HPRA).
Eli Lilly Support Member Jobs
Responsibilities:
1. UK/IE PhV Affiliate Responsibilities
Establish and maintain Lilly’s UK/ IE PhV operations, monitor status of the quality system and pharmacovigilance activities, and sustain / promote compliance to legal requirements and relevant Good Vigilance Practices.
Oversee UK/ IE PhV operations (e.g., adverse event management, expedited and periodic reporting, risk management and maintenance of the PhV System Master File), implementing improvements and leading corrective / preventative actions, whenever applicable.
Act as National Contact Person for Pharmacovigilance as required by the Medicines and Healthcare products Regulatory Agency (MHRA).
Understand the Global and/or European Qualified Person for Pharmacovigilance (QPPV) roles and obligation
Liaise with Qualified Person for Pharmacovigilance to ensure compliance to applicable company requirements and UK/IE pharmacovigilance regulations.
Escalate safety and compliance issues to appropriate local / global management and assure appropriate communication between UK/ IE safety personnel and stakeholders (e.g., Global Patient Safety (GPS), Regulatory Affairs, Medical).
Provide technical expertise on the interpretation and implementation of national PhV legislations, for both drugs and devices, to the UK/ IE affiliate and GPS.
Ensure PhV related SOPs are well understood across the aligned affiliates, leading and providing clarifications during local implementation.
Lead / coordinate / organize all necessary training on adverse reporting to the UK/IE affiliate.
Review and approve local business / safety agreements impacted by PhV regulatory requirements (e.g., Business alliances, Patient Support Programs, distribution agreements).
Collaborate with external customers and be an active participant in local pharmacovigilance industry association groups.
Recruit, train and develop individuals to work with a high-quality standard and achieve department and company objectives.
Manage UK/ IE PhV team’s performance and development, retaining talented employees and maximizing value delivered to the corporation.
Oversight of local Risk Management Plans, including implementation of Risk Minimization Activities in the UK/IE countries and appropriate documentation of Risk Minimization Plan activities to ensure compliance with requirements, guidelines, and regulatory commitments.
Strive for inspection / audit readiness and collaborate in inspections / audits involving UK/IE affiliate PhV operations.
Responsible for actioning or implementing business continuity planning as required.
Eli Lilly Support Member Jobs
2. GPS Safety Management Responsibilities
Contribute to the GPS strategy, being a change agent to support the organization to meet long-term objectives.
Actively participate in GPS projects/process improvements, and manage the change controls, gap analyses, and global shared learnings.
Provide oversight of on-boarding and mentoring to new employees (both internally and externally).
Review documentation and training materials and collaborate with Business Units, the Medicines Development Unit (MDU), and GPS areas.
Develop and maintain expertise on pharmacovigilance regulations and add value to global teams by sharing knowledge EU regulatory requirements.
Review PhV legislation changes and update internal Safety Management procedures, accordingly, partnering the Medicines Quality Organization and Information Technology.
Support Regional Centers, other global affiliates and compliance oversight (medicines quality) organisation during audits and inspections, and provide responses to Safety Management related observations.
Basic Requirements:
Bachelor’s degree (or higher) in physical or biological sciences (or equivalent demonstrated experience).
Relevant pharmacovigilance experience relating to management of ICSRs, expedited reporting and periodic reporting.
Deep understanding of EU and UK/IE PhV regulatory landscape (relevant guidelines and legislations).
Excellent communication (written and verbal), interpersonal, organizational and negotiation skills.
Eli Lilly Support Member Jobs
Additional Skills/Preferences:
Significant experience within pharmacovigilance field.
Previous experience in leading/ supervising teams preferred.
Previous experience leading audits and inspections, and robust understanding of quality management system.
Demonstrated ability to implement, interpret, and apply pharmaceutical regulations.
Prior clinical experience i.e. nursing, pharmacy preferred.
Project management expertise with proven ability to oversee and manage multiple tasks/processes simultaneously.
Eli Lilly Support Member Jobs
About the Eli Lilly Company :
Eli Lilly, a renowned pharmaceutical company, has made significant strides in the United Kingdom’s healthcare landscape. With a history dating back to 1876, Eli Lilly has established itself as a global leader in the development and production of innovative medicines.
In the UK, Eli Lilly operates as an integral part of the healthcare ecosystem, focusing on research, development, and distribution of medications to address various medical conditions. The company’s commitment to innovation is reflected in its diverse portfolio, spanning therapeutic areas such as diabetes, oncology, neuroscience, and immunology.
One of Eli Lilly’s notable contributions to the UK healthcare system is its dedication to addressing unmet medical needs. Through ongoing research and development efforts, the company strives to bring forward novel treatments that improve patient outcomes and quality of life.
Moreover, Eli Lilly emphasizes collaboration with healthcare professionals, academic institutions, and government agencies to foster a comprehensive approach to healthcare delivery. By engaging in partnerships and initiatives, the company aims to enhance access to healthcare services and promote health equity across diverse populations.
In addition to its focus on drug development, Eli Lilly prioritizes corporate responsibility and sustainability. The company is committed to ethical business practices, environmental stewardship, and community engagement initiatives that positively impact society.
Overall, Eli Lilly’s presence in the United Kingdom is characterized by its commitment to advancing healthcare through innovation, collaboration, and social responsibility. As the company continues to evolve and expand its footprint, its contributions to the UK healthcare landscape are poised to remain significant in the years to come.
Eli Lilly Support Member Jobs
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