Drug Safety Case Entry, Contract ARISg/LSSMV (20 hours weekly)
Santen is a specialized pharmaceutical company with a 130-year heritage focused exclusively on ophthalmology. With sales in over 60 countries, Santen’s 4,000 global employees work to deliver life-changing therapies that make hope a reality for people facing vision impairment and loss. Santen Inc., located in Emeryville, CA (North America HQ), contributes important research & development and commercialization efforts. This office is home to about half of our 300-total staff in North America, including our Toronto, Canada site and our recent acquisitions of Eyevance Pharmaceuticals (Fort Worth, TX) and InnFocus (Miami, FL).
We are in search of top talent to help us meet our important goals and large growth plans.
ABOUT THE POSITION:
The Drug Safety Associate will providing specific tasks support to Santen’s continued growing and exciting pipeline of Santen 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.
Note: This is a part-time contract position (20 hours weekly) that has the possibility of converting to a full-time role in 2022. ArisG/LSSMV experience is required. Occasional onsite work, such a half-day once per week, at Santen in Emeryville, CA is required. Relocation is not available.
At this time, we are seeking candidates with availability to start in October 2022.
This is a W-2 contract position through our preferred vendor. You will be guaranteed 0.5 (20 hours per week and not all hours will have to be onsite in Emeryville, though some will).
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 Santen Safety Database System performing such steps as Data Entry, Triage, Distribution, follow-up, etc. This may involve database systems such as ARIS G LSSMV 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
- 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 Santen’s 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 Santen INC input.
Core Competencies, Education, & Experience:
- 2 or greater years of safety experience in the pharmaceutical industry
- Must be comfortable working 20 hours weekly performing primarily drug safety case entry tasks on a long-term contract (W-2) basis.
- Understanding of pharmacovigilance/drug safety, lifecycle of a safety case (SAE/AE)
- Experience with ARISg/LSSMV safety database is REQUIRED
- Understanding of FDA and other HA 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
- Emeryville, CA
COVID-19 Vaccination Requirement: Santen requires anyone working on-site or visiting company offices to confirm they are fully vaccinated against COVID-19 unless a medical or religious accommodation is timely requested and approved. Please reach out if you have questions or concerns about this policy and how it may apply to your candidacy for a role with Santen.