Drug Safety Associate I

Recruiter
DOCS Global
Location
Bedfordshire
Posted
12 Oct 2018
Closes
14 Oct 2018
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
Roles & Responsibilities of the positionTo meet and maintain Regulatory and Internal Quality Compliance in case management activities; duties include but are not limited to:
• Accreditation in case management through completion of the induction training, passing of associated exams and successful completion of the mentor- lead case processing training.
• Complete and accurate data collection and entry of adverse event reports in the Argus Lilly Safety System (LSS).
• A detailed understanding of GPS SOPs and Safety Quality Systems regarding management of adverse event reports with the ability to explain these concisely to others and generate clear understanding of requirements.
• Comply with internal/external timelines for managing adverse event data entry, and escalate any identified significant safety or compliance issues in case management as appropriate.
• Typical Drug Safety Associate I activities include (but are not limited to):
I. Receipt, validation, and analysis of source document(s) and completion of data entry in LSS as appropriate.
II. Perform assessment of expectedness of adverse events against the Reference Safety Information, as required.
III. Create a case narrative.
IV. Perform a post data entry quality check for completeness, consistency, and adherence to GPS standards.
V. Determine if physician safety review is necessary and route case to the next appropriate workflow state.
VI. Determine most appropriate opportunity to obtain complete case data and follow up questions.
VII. Escalate through appropriate communications any identified process improvements.
VIII. Manage timely completion of case action items by due date in system to 100% compliance
IX. Complete case processing activities related to business partnerships as per requirements.
X. Review and amend cases based on feedback from quality reviews performed.
XI. Working towards attaining, or having attained, exemption from In Progress Review.Job RequirementsMinimum Requirements (include requirements for education, work experience, and skills)
• Education: Bachelors degree (or higher) in a healthcare-related field or life sciences field or demonstrated equivalent experience is required
• Demonstrate basic clinical knowledge of various disease states
• Effective communication skills (verbal and written)
• Demonstrate competency in IT platforms including databases, Microsoft Office
• Ability to manage multiple concurrent tasks, good organizational skills, attention to detail, ability to focus for long periods of time on detailed information, consistently prioritize work and make decisions that comply with applicable timelines
• Effectively analyse possible solutions to solve a range of problems
• Effectively respond to customer requirements and requests
• English language skills – fluent written and verbal communications

Preferred Skills:
• Knowledge of global regulations with respect to adverse event reporting
• Knowledge and understanding of GPS policies and procedures
• Ability to working autonomously, influencing without authority, ability to network ideas in corporate environment
• Ability to learn quickly and adapt to a changing environment
• Flexibility to adapt to changing priorities
• Demonstrated interpersonal skills; ability to work as part of a team
• Ability to see the big picture; use logic to solve problemsRemuneration & other details• Permanent position
• Working for a leading Pharma company
• Full time
• Competitive salary and benefits on offer

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