- Experience Level
- Experienced (non-manager)
•Prepare and maintain the periodic reporting calendar, communicating amendments to key stakeholders (Medical Organisation, Safety Management, Central Regulatory Registry, Global Affiliates) as appropriate
•Distribute periodic safety reports to global publishing team and global affiliates in an efficient and timely manner to ensure regulatory compliance
•Record, monitor, and tracking periodic safety report submissions to EMA and Regulatory Authorities
•Ensure on-time exchange and tracking of periodic safety reports and Risk Management Plans with business alliance partners
•Communicate effectively with internal and external business partners to ensure outputs and reports comply with global procedures
•Adhere to quality systems requirements, and maintain tracking systems / procedure documentation
•Delivers quality and compliance in line with documented procedures and expectations, including those in program performance measures.
•Aware of importance of own role and able to define where it fits into the wider department organisation with awareness of up and downstream activities.
•Aware of the QPPV role and their responsibilities.
•Supports inspection readiness through own activities and aware of why audits/inspections are conducted
•Aware of the departmental Business Continuity Plan and when it may be implemented
•Other responsibilities may be assigned as appropriate and at the discretion of DOCS and Lilly management.
EXPERIENCE, SKILLS, KNOWLEDGE REQUIREMENTS
•Effective communication skills (written and verbal), fluent in English
•Proficient in Microsoft Office suite
•Knowledge of medical and therapeutic terminology
•Excellent organisational and time management skills with proven ability to prioritise and manage multiple deliverables
•Ability to work independently with guidance from procedural documentation, and appropriate support
•Excellent attention to detail
•Effectively respond to requirements and requests
•Knowledge of global regulations with respect to collection of adverse event information.
•Knowledge of medical coding systems
•Ability to work autonomously, influencing without authority, ability to network ideas in corporate environment.
•Provide and apply constructive feedback to / from colleagues.
•Ability to learn quickly and adapt to a changing environment.
•Flexibility to adapt to changing priorities.
•Demonstrated interpersonal skills.
•Ability to see the big picture; use logic to solve problems.
Remuneration & other details
•Full time - Office based Bracknell
•Training Fully provided
•Competitive salary and benefits package
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