DOCS Global

Surveillance Specialist

Bracknell, UK
19 Feb 2021
24 Feb 2021
Full Time
Contract Type
Experience Level
Experienced (non-manager)
Key Responsibilities

1. To perform specific safety surveillance activities in support of the late lifecycle portfolio:

*Effectively utilize available tools to perform assigned safety deliverables. Consult and collaborate with safety physicians and other appropriate personnel to effectively complete assigned safety deliverables. Communicate relevant safety information appropriately and in a timely manner. Author safety sections, perform analysis of safety data, and provide oversight of timelines and other contributing functional areas to ensure completion of periodic reports such as Periodic *Benefit Risk Evaluation Reports (PBRERs), Development Safety Update Reports (DSURs), Periodic Adverse Drug Experience *Reports (PADERs) and Risk Management Plans (RMPs).
*Complete safety data analysis and authoring of safety sections for ad-hoc safety reports and routine surveillance purposes.
*Understand the roles and responsibilities of the EU Qualified Person for Pharmacovigilance (QPPV) and ensure support is provided to fulfill the QPPV legal responsibilities.
*Adhere to requirements in quality system documents for assigned safety deliverables to ensure compliance with local laws and regulations.
*To ensure effective communication and cross-functional collaboration: Global Patient Safety support
*Understand and apply GPS business practices.
*Adhere to requirements in quality system documents and process improvement initiatives to ensure compliance with local laws and regulations
*Proficient in liaising with members of the global GPS team.
*Develop an understanding of the roles and responsibility of the European Union Qualified Person for
Pharmacovigilance (QPPV).
*Represent case management across teams.
*Provide cover for colleagues.

Support internal/external customers

*Responsible for effective communication with internal Lilly
*Support affiliates, business units and other functions in GPS related activities as necessary.-
*Adhere to confidentiality guidelines with an understanding of the confidential nature of company information, and take all necessary steps to ensure its.

To ensure pro-active personal development/teamwork and people development:

*Drive own development to become an effective and productive Surveillance Specialist.
*Take ownership/accountability of, and effectively prioritize, own workload to ensure all agreed objectives/deadlines are met.
*Consistently meet individual productivity and quality targets and other goals established in Program
*Performance Measures and individual goals / objectives.
*Solve problems proactively by identifying and resolving issues with limited assistance (if required) and escalating when appropriate.
*Identify and act on internal process improvements in product safety standards and practices.
*Collaborate with colleagues across all regional centres to share learnings and best practices.
*Provide and apply constructive feedback to/from colleagues in particular with regards to quality reviews performed and mentoring.
*Regularly communicate with colleagues and management with regards to both team, and individual, workload, capacity and efficiency.

Minimum Requirements/Additional Preferences

*At least two years of experience in pharmaceutical industry, retail pharmacy, hospital or clinical setting,
*Experience within GPS or demonstrated understanding of Pharmacovigilance and Pharmacoepidemiology,
*Clinical knowledge of various disease states, drug effects, human physiology and pharmacology,
*Effective communication skills to interact with diverse groups and individuals,
*Demonstrated ability to provide risk-based decision making in a regulated environment,
*Demonstrated ability to manage multiple deliverables simultaneously,
*Effective communication skills (verbal and written).
*Proficient in Microsoft Office suite.
*Knowledge of medical terminology and coding systems.
*Ability to manage multiple concurrent tasks.
*Excellent organizational and time-management skills.
*Effectively analyze possible solutions to solve a range of problems.
*Effectively respond to client requirements and requests.
*English language skills - fluent written and verbal communications.
*Work effectively in team environment.

Other Information
*Knowledge of global regulations with respect to case management.
*Knowledge and understanding of GPS policies and procedures.
*Ability to working 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.

Minimum Requirements

Bachelors, Masters, and/or Doctorate degree in a healthcare field or degree in a science field with equivalent demonstrated clinical experience.

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