PV Senior Scientist
- Remote, Home Office, United States
- Department: Global Patient Safety
Aurinia exists to make a difference in transforming people’s lives by delivering innovative treatments to patients living with serious, rare autoimmune and inflammatory diseases. From the earliest days of the company, we’ve applied an inventive, thoughtful, and responsible approach to developing therapies for people in need. Through our dedication, we relentlessly preserve and execute with integrity to reach our main objective, to improve patients’ health. In addition to driving adoption of our approved therapy, LUPKYNIS™, for appropriate people with lupus nephritis, we are also actively pursuing a broader portfolio of innovative drugs for autoimmune disease.
Our strategy leverages the skills and knowledge of our incredible team and our deep experience in principled drug development and commercialization. Aurinia provides a working environment where individuals can thrive in a professional, creative, and inspirational atmosphere. Together, we are driven to make an impact for our patient communities as advocates and partners in innovation.
Aurinia’s Global Patient Safety (GPS) team is a newly established centralized department recently launched in Q1 2021. GPS is tasked to provide pharmacovigilance/patient safety and risk management subject matter expertise.
We are seeking a talented Pharmacovigilance Scientist to join our growing GPS team at this critical and exciting time in Aurinia and its commitment to its patients.
In this newly created role and position, the ideal candidate will bring subject matter expertise in Pharmacovigilance Science to help establish and develop this function at Aurinia under the guidance and leadership of the Head of GPS.
Clinical Trial Safety
·Serve as the primary GPS SME, working in collaboration with the GPS MD + GPS Associates/Operations.
·Reviews clinical study-related documents impacting patient safety and brings observations to GPS and clinical teams.
·Reviews AE coding and oversees reconciliation activities for safety data from clinical studies.
·Contributes to Safety Management Plans for Clinical Trial programs.
·First pass review of standard design of tables, figures and listings for safety data from clinical studies and liaises findings to GPS MD.
·Reviews, documents, and escalates concerns and issues to GPS management.
Periodic (Aggregate) Safety Reporting
·Supports and project manages the activities related to the aggregate report preparation with other functions involved, in collaboration with the assigned external vendor.
·Provides input and review for aggregate reports (i.e., DSUR, IND annual, 6-month line listings, etc.) for submission to the health authorities and other stakeholders, as needed.
·Provides assistance with the preparation of safety reviews to address specific safety issues when needed.
Submissions and Other Regulatory Filings
·Assists in the preparation and review of safety assessments and evaluations for ad hoc. regulatory safety reports such as responses to health authorities’ requests, Health Hazard Evaluation, and responses to inquiries from internal and external customers.
·Provides GPS input to the development of product Reference Safety Information (Core Company Safety Information, Developmental Core Safety Information, Investigators Brochure, etc.).
Signal Detection, Evaluation, And Management Support
·Alert appropriate management as soon as a potential signal or trend is recognized.
·Performs case series review or review of tabulated data as preparation for team interpretation of reviewed data.
·Maintains schedules, minutes, tracking sheets and ensure follow-up of decisions and assigned tasks for relevant safety activities.
·Assists in the preparation of presentation materials, documents and white papers when needed, including documentations supporting the decision process through the established safety governance model in place.
·Primary GPS responsible for literature case review and assessment, coordinating the PV CRO activities.
·Participates in the preparation of GPS responses of Medical Information Inquiries as requested.
·Conducts research as needed and produces summaries for GPS team review and use (BD including competitor analysis, published and unpublished literature, public regulatory sources, etc).
•Pharmacy / PharmD degree with 3-5 years of direct PV experience, or MS in health-related field or BSN with 5 or more years of direct PV experience, or BS in life sciences related field with 5 or more years direct PV experience.
•In depth understanding of medical terminology.
•In depth knowledge of global clinical safety regulations, guidances, and reporting processes.
•Direct experience related to PV Signal Detection activities
•Experience with MedDRA coding and safety database systems.
•Proficient in the Office suite of programs (Word, Excel, Power Point).
•Able to effectively communicate in a clear manner.
•Proven ability to critically think through complex medical/safety reports and effectively summarize key information in a concise narrative presentation.
•Ability to influence others and accomplish goals within a team environment.
•Flexible, highly organized with the ability to prioritize.
•Ability to take on the challenge of unfamiliar tasks and learn quickly in an evolving function and organization.
•Strong interpersonal skills.
•Strong commitment to business ethics.
•Knowledge and experience with safety surveillance, signal detection, labeling analyses, and ad hoc safety analyses.
•Experience in the review of relevant safety information from all sources and analysis of safety data.
•Experience with development, authorship and review of aggregate reports (i.e., PSUR, DSUR, IND annual, NDA annual, etc.), Risk Management Plans, and Risk Evaluation and Mitigation Strategies.
•Experience with safety surveillance and regulations for global early access/compassionate use programs.
•Experience in vendor management.
All candidate information will be kept confidential according to EEO guidelines.