5899 Preston Rd, Suite 501
Frisco, TX, United States
I.T. & T.
Truminds Technologies Inc
Work from Home Available:
The Senior Drug Safety Associate will providing specific tasks support to our client’s continued growing and exciting pipeline of products (medicinal products and medical devices) coming through the area of ophthalmology. This person will act as the primary point of contact for Safety Vigilance case data entry, triage, communication and distribution, departmental support, and cross-functional collaboration.
Essential Duties and Key Deliverables:
Monitor multiple points of Safety information communication including email, fax, electronic data capture systems such as RAVE for all communication, then assimilate information based on defined workflow
Process SAE/AE and medical device reports into the Safety Database System performing such steps as Data Entry, Triage, Distribution, follow-up, etc. This may involve database systems such as ARIS G, ARGUS g, and TrackWise.
Assist with safety case reconciliation with external vendors
Assist with maintenance of safety documentation in VeevaeTMF
Provide administrative support to the department: schedule departmental meetings, send out agenda prior, take meeting meetings, distribute meeting minutes/action items post, any required follow-ups
Collaboration and communication with Data Management/Stats, Clinical Operations, Regulatory Affairs, Medical Affairs, Commercial (Sales/Marketing), and other functions as needed
Support Change Controls lifecycle for Safety Database Systems, utilizing in-house system as well as COTS
Act as liaison between internal cross-functional groups, to ensure gaps are identified and mitigated
Cross-functional communication of safety initiatives
Provide support to PV SOPs (local and global), utilizing Veeva Quality Docs (VQD) – including maintenance of safety documentation in VQD.
Provide guidance & support, including reviewing, revising, creating Safety SOPs, Work Instructions and Quality Manuals (QM) to obtain a post-marketing milieu ready case processing and signal detection system.
Participate in global safety operations and safety database committees and task forces to provide INC input.
6 or greater years safety experience in pharmaceutical industry
Deep understanding of pharmacovigilance/drug safety, lifecycle of a safety case (SAE/AE)
Deep understanding and experience with safety database systems such as ARGUS or ARIS LSSMV
Understanding of FDA regulations, and regulatory submissions
Understanding and experience with Trackwise (product complaints, CAPA, deviation); to be able to provide support to PV
Understanding and experience with data management systems (EDC, Medidata RAVE/Balance); understanding and experience with Clinical Operations systems (eTMF)
Understanding and experience with Veeva Quality Docs (VQD) for SOPs (local and global)
Project Management skills, ability to handle multiple tasks with ongoing time management
Life Sciences background a plus, but not mandatory
Proven ability to work on multiple projects/initiatives at the same time
Strong communication, collaboration (global-scale), and forward-thinking skills while providing local support.