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7 days old

Drug Safety Associate

Kelly Services
Emeryville, CA 94662
**Job Title:** Drug Safety Associate





**Job Description:**



The Senior Drug Safety Associate will providing specific tasks support to our clients 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 Veeva eTMF




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.




**QUALIFICATIONS:**


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






**Why Kelly** **** **?**



Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.




**About Kelly** ****



At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.

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Posted: 2020-10-16 Expires: 2020-11-16

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Drug Safety Associate

Kelly Services
Emeryville, CA 94662

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