
25 Sep IT Drug Safety Analyst
IT Drug Safety Analyst
Technology and Digital Health · South San Francisco, CA · Full time
At Alector, our mission is to develop therapies that empower the immune system to combat neurodegeneration. Our team is solely focused on developing treatments for some of the most challenging diseases facing our society. We are supported in this mission by experienced and accomplished scientists and clinicians, leading healthcare investors, and pharma company partners who share in our commitment to bettering the lives of patients.
Use your hard-earned software implementation, validation and business partnership skills to help us achieve our mission of saving lives.
As the IT Drug Safety Analyst for the Alector team, you will work with the Sr. Director IT Business Partner to provide operational support to maintain and enhance systems that support Alector’s Pharmacovigilance Organization.
Core Responsibilities
- Provide Operational Support (includes management of system access and permissions and monitor health of Veeva Vault Safety system)
- Perform change management activities per established Change management procedures
- Engage with users and Veeva technical team to analyze and resolve issues in a timely manner
- Maintain Systems and systems Operations/Administration documentation
- Analyze user enhancement requests to deliver solutions focused on establishing and improving business processes that improve efficiency, address process gaps, and enable automation and growth of the organization
- System Administration Experience with Veeva Vault Safety and/or other Safety systems
- Experience working with Pharmacovigilance colleagues on issue resolution and system improvements
- Experience with dictionary management (WHODrug and MedDRA) and upgrades
- Experience with PV reporting processes (e.g. DSUR)
- Database and Computer Networking Knowledge
During the first 90 days, your goals will include:
- Taking system ownership of the Veeva Vault Safety System
- Taking ownership of Veeva Vault Safety System change processes
We’d love to hear from you if have:
- Proven ability working on validated Safety Systems applications in a pharmaceutical or regulated environment (preferably Vault Safety).
- Experience and knowledge of the safety and quality business processes.
- Direct hands-on experience implementing GxP computerized systems and maintaining systems in a validated state.
- Strong analytical skills using technologies like Excel, Power BI etc.
- Must have demonstrated technology skills maintaining and enhancing system capabilities.
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Alector is a phenomenal place to learn and experiment. If you excel in a dynamic environment where everyone is committed to finding a treatment, where you’ll drive growth, this is your role. There is no limit to how far you can go with us.
Among the things you’ll discover at Alector on Day 1 and throughout your tenure: Committed and driven colleagues, a bold and important company goal, brand-new brightly-lit offices in the heart of the biotech area, flexible remote work options, and competitive compensation and benefits. But these matters only if you’re excited to build and own something great, and tackle these challenges with us. Come join us!
At Alector, we believe that hard-working teams include people from a wide variety of backgrounds and experiences who can challenge each other’s assumptions with fresh perspectives and bring creative ideas to the table. We are committed to building an open, diverse, and inclusive environment for all employees. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, sexual orientation, age, marital status, veteran status, or disability status, or any other characteristics protected under applicable federal, state, or local laws.
Employees of Alector working on-site are required to be vaccinated against COVID-19, and are required to provide proof of vaccination. Employees may be entitled to an exception or reasonable accommodation if they cannot be vaccinated because of a disability/medical necessity, or sincerely held religious belief.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Please click here to apply.
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