Senior Business Systems Analyst, Drug Safety and Pharmacovigilance, Information & Systems
Pharmacyclics is committed to the development and commercialization of novel therapies intended to improve the quality and duration of life and to resolve serious unmet medical needs for cancer patients. Pharmacyclics is a wholly-owned subsidiary of AbbVie (NYSE:ABBV), a global, research-based biopharmaceutical company. Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products and a pipeline containing multiple promising new molecules that are being studied in more than 200 clinical trials for over 20 different types of cancer.
More than 1,200 Pharmacyclics and AbbVie research scientists, clinicians, marketing, operations and corporate professionals work in the San Francisco Bay Area. They combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. Together, we are striving to outsmart cancer.
To learn more about us, please visit us at http://www.pharmacyclics.com/
General Position Summary/Purpose:Execute and/or oversee all functions of Drug Safety Systems in meeting Drug Safety and Pharmacovigilance departmental objectives for overall compliance as outlined by the VP, Drug Safety. Reporting to Senior Manager, Drug Safety and Pharmacovigilance, Information & Systems. Performing as an individual contributor in a fast paced, growing organization. Key Accountabilities/Core Job Responsibilities:
- Support the day-to-day running of applications to sustain Drug Safety objectives, including Argus Safety, MedDRA, Data Warehouse and Business Reporting tools
- Assist with quality review of configuration of PV Safety Systems for products, studies, user privileges and workflow.
- Perform programming, validation, and generation of custom reports for data analysis to meet internal business requirements based on contracted timelines.
- Understand regulatory changes as they impact the company.
- Take part in impact analysis of changes to Drug Safety Systems identifying the risks, benefits and costs associated with the change.
- Review training documentation for Drug Safety SOPs related to PV Safety Systems and data management
- Support Drug Safety Dictionary version management, such as MedDRA, WHO dictionaries, and upgrades as required by Drug Safety Operations.
- Act as liaison with IT and external vendors to support delivery of computing infrastructure
- Act as liaison with Business Partners to support ongoing needs of Pharmacyclics and partners.
- Maintain compliance with relevant policies and procedures
- Support the investigation and resolution of complex, cross-functional issues using strong problem solving abilities
Qualifications and Requirements (degree, certifications, etc. and other requirements):
MS in technical field preferred; BS in technical field required
Minimum 3-5 years of experience within pharmaceutical industry required, including 1 years of experience with validated drug safety systems and applications
Understanding of FDA regulations supporting the submission of adverse events for post-marketing and investigative drugs
Understanding of ICH guidelines
Understanding of MedDRA structure
Understanding and application of guidelines detailed in FDA 21 CFR Part 11, including system validation requirements
Advanced knowledge of Oracle databases, PLSQL and SQL programming
Advanced skills in report generation using business intelligence tools (Business Objects, Cognos, etc.)
Advanced understanding of database architecture (Argus Safety Database preferred)
Ability to troubleshoot complex problems, involve multiple teams/departments in the investigation and assessment of the problem and proposed solutions.
High level of proficiency with MS Office applications
Basic knowledge of scientific terms and medical terminology
Solid written, verbal communication, and interpersonal skills
Time management and ability to prioritize workload
Quality orientation: attention to detail, accuracy
Understanding of training concepts
Ability to exhibit project management skills
Basic understanding of documentation requirements (Gxp) in a regulated environment
Basic knowledge of tools used in controlled document environments and tools used in software development.