Ref #: 29201

Employment type: Permanent - Full-Time

Location: Bracknell - United Kingdom

Posted: 14-May-2021

Description

Key Responsibilities
To meet and maintain Regulatory and internal quality compliance in case management activities through:

Proficient in performing data entry of adverse event information in the Lilly Safety System in line with documented internal procedures and external regulations:
o Proactively accept assigned cases and complete triage based on key fields to determine priority
o Perform assessments of expectedness against Reference Safety Information
o Prepare case narratives
o Seek support from peers and Subject Matter Experts to ensure encountered scenarios
are understood and interpreted correctly
o Accurately determine subsequent workflow steps
o Identify missing or inconsistent data and prepare clear concise queries to request this
information
o Complete action items by due dates set
o Concisely explain to others these requirements
Proficient in handling adverse event reports from a variety of different case types, therapeutic
areas and methods of receipt.

Complete accurate data entry:
o Perform a post data entry quality check for completeness and consistency
o Run validation checks within the Lilly Safety System and amend entry as required
o Review and amend cases based on feedback from quality reviews performed
o Perform peer quality IPR review with demonstrated ability to provide clear concise
feedback
o Takes steps to avoid late reporting and CAPAs
o Escalate any identified safety or compliance issues
Comply with internal and external case handling timelines.
Complete case acceptance activities, and proactively communicate emergent due dates within the

GPS case management team
o Prepare rotas for local and global processing teams to ensure all team activities are appropriately covered
o Display familiarity with protocols/products from assigned therapeutic area(s), and proficiency across all other therapeutic areas.
o Consistently deliver required productivity levels to support achievement of targets set for DOCS
and within the GPS case management team.
o Act as mentor for colleagues in case management activities, such as the new hire accreditation or for case handling tasks like case acceptance.
o Present training on case processing topics

To meet and maintain Regulatory and internal quality compliance in expedited reporting activities through:

o Review, assess and distribute expedited reports to regulatory authorities from clinical and/or spontaneous sources (MHRA, HPRA, EMA)
o Review, assess and distribute reports for medical devices
o Clear understanding of the legislative requirements for these reports
o Awareness of requirements for submissions to ethics bodies and investigators

Knowledge and understanding of role:

Has a developed understanding of the GPS SOPs and Safety Quality Systems regarding management of adverse event reports. Effective at issuing colleagues with correct guidance.

Aware of importance of own role:
o Can define where it fits into the wider GPS department
o Able to identify workflow steps within case handling pathways, up and downstream of
o Able to define recipients of individual safety reports and the criteria used to determine
qualifying reports
o Has an understanding of legislative requirements that define their activities
o Clear understanding of the QPPV role and their responsibilities
o Supports inspection readiness through own activities and aware of why audits/inspections are conducted
o Aware of the Departmental Business Continuity Plan and when it may be implemented

Professional competencies:

o Communicates clearly and effectively verbally and in written formats in a variety of settings.
Developing skills as a confident presenter.
o Demonstrated ability to prioritise workload and complete all deliverables (including but not limited to assigned workload, action items, weekly timesheets, and performance management activities) by deadlines set
o Escalates issues effectively and proposes potential solutions based on own experiences
o Makes objective, informed, experienced based and evidence based decisions, taking ownership of outcomes
o Use relationships established with local and global GPS colleagues to work collaboratively. Able to identify expectations and show commitment to meeting them.
o Uses feedback as a tool to influence self-development. Proven ability to provide clear constructive feedback regarding processes and delivery. Developing mentoring style.
o Adheres to confidentiality guidelines and expectations with an understanding of how to identify and protect company information
o Displays integrity

Training and Development:

o Compliant with all DOCS and Lilly training requirements
o Committed to developing self and has clearly defined development goals aligned to career aspirations
o Demonstrates understanding of how metrics define their role and are used to support
o Performance Management Processes

The above is not a comprehensive list of activities that may be completed by individuals in the Drug Safety Associate II role, and some responsibilities described or additional responsibilities will be assigned based on business need. DOCS operate a stratification within the team and individuals will be expected to be performing some core responsibilities associated with the Senior Drug Safety Associate role before considered for any promotion. Other responsibilities may be assigned as appropriate and at the discretion of DOCS and Lilly management.

Minimum requirements:

o Effective communication skills (written and verbal), fluent in English
o Proficient in Microsoft Office suite
o Knowledge of medical terminology and coding systems
o Ability to work autonomously, influencing without authority, ability to network ideas in corporate environment.
o Excellent organisational and time management skills with proven ability to prioritise and manage multiple deliverables
o Detail orientated
o Effectively respond to requirements and requests
o Demonstrated good interpersonal skills. Preferred requirements:
o Knowledge of global regulations with respect to case management.
o Provide and apply constructive feedback to / from colleagues.
o Ability to learn quickly and adapt to a changing environment.
o Flexibility to adapt to changing priorities.
o Ability to see the big picture; use logic to solve problems.

Minimum Requirements (include requirements for education, work experience, and skills)

Bachelor’s degree (or higher) in a healthcare-related or life science field Or, demonstrated equivalent experience
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