Ref #: 25097

Employment type: Permanent - Full-Time

Location: Drug Safety Associate

Posted: 10-Nov-2020

Description

We are looking for a dedicated and passionate DSA to join our team working with a market leading Pharma Company.

At DOCS we care about our people as the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.

Key Responsibilities

To meet and maintain Regulatory and internal quality compliance in collection of adverse event information from UK and ROI through:
•Receive and review adverse events reports received:
•Proactively accept assigned workload and determine priority
•Assess the information received for completeness and accuracy, and acknowledge receipt if appropriate
•Perform a duplicate check within our clients Safety System
•Complete entry of key fields within our clients Safety System to register the case
•Concisely explain to others these requirements
•Complete accurate data entry:
•Perform a post data entry quality check for completeness and consistency
•Run validation checks within the clients Safety System and amend entry as required
•Perform peer quality review with demonstrated ability to provide clear concise feedback
•Takes steps to avoid late reporting and CAPAs
•Escalate any identified safety or compliance issues
•Prepare and distribute follow up queries as directed by case management or medical review colleagues
•Comply with internal and external case handling timelines.
•Ensure source documentation received is maintained within designated filing structure
•Act as mentor for colleagues in case handling requirements
•Review, assess and distribute individual and periodic expedited reports to Ethics Bodies
•Able to use, navigate and troubleshoot websites used by Ethics Bodies for receipt of submission documents
•Perform peer quality review to ensure accuracy of submissions
•Understanding of the legislative requirements for these reports
•Awareness of requirements for submissions to Regulatory Authorities and investigators
•Keep accurate details of completed submissions in designated tracking tools
•Act as back-up to Periodic Reports Coordinator

Owns partner relationships for collection of adverse event information
•Examples may include, but are not limited to:
•Patient Support Programs (PSPs)
•Market Research (MR) Programs
•Medical Information
•Other Third Party Organisations (TPOs)
• Builds relationships with internal and external partners
• Displays ownership of assigned project by:
•Preparing project documentation with support, clearly defining adverse event collection methods and reporting pathways
•Perform training of partners and providers in our clients expectations and processes
•Ensure consistency with our clients processes and requirements
•Provide advice and guidance to partners and providers
•Works collaboratively with Operations Team management and colleagues
•Monitor program status and provide clear accurate reports to partners and our clients management
•Lead meetings with partners
•Perform reconciliation activities

Maintain and update the EMA master data repositories, including XEVMPD
•Perform maintenance and updating of licence information for our clients developmental and marketed products within the XEVMPD system
•Perform maintenance and updating of our clients information to ISO IDMP standards in required EMA master data repositories
•Build relationships with our clients partners (for example Global Regulatory Affairs, Affiliate offices) to ensure required information is collected, recorded and tracked
•Support requests for information from other of our clients Functional Teams
•Develop an awareness of the requirements and regulations for maintaining the dictionary and describe those related to assigned responsibilities
•Meet internal procedure and external regulatory timelines
•Able to identify and define the regulatory status of each of our clients product

Maintain and update the Our Clients PSMF
•Assist in preparing updates to the PSMF pertaining to job function
•Work collaborative with partner functions to ensure information is collected, tracked and updated within internal procedural and external regulatory timelines
•Display an understanding of the regulations related to updating and maintaining a PSMF

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:
•Can define where it fits into the wider GPS department
•Able to identify workflow steps within case handling pathways, up and downstream of
•Able to define recipients of individual safety reports and the criteria used to determine qualifying reports
•Has an understanding of legislative requirements that define their activities
•Clear understanding 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

Professional competencies
•Communicates clearly and effectively verbally and in written formats in a variety of settings. Developing skills as a confident presenter.
•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
•Escalates issues effectively and proposes potential solutions based on own experiences
•Makes objective, informed, experienced based and evidence based decisions, taking ownership of outcomes
•Use relationships established with local and global GPS colleagues to work collaboratively. Able to identify expectations and show commitment to meeting them.
•Uses feedback as a tool to influence self-development. Proven ability to provide clear constructive feedback regarding processes and delivery. Developing mentoring style.
•Adheres to confidentiality guidelines and expectations with an understanding of how to identify and protect company information
•Displays integrity

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
•Effective communication skills (written and verbal), fluent in English
•Proficient in Microsoft Office suite
•Knowledge of medical terminology and coding systems
•Ability to work autonomously, influencing without authority, ability to network ideas in corporate environment.
•Excellent organisational and time management skills with proven ability to prioritise and manage multiple deliverables
•Detail orientated
•Effectively respond to requirements and requests
•Demonstrated good interpersonal skills.