Our Mission & Strategy

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 is seeking a talented Pharmacovigilance Leader to join our growing GPS team at this critical and exciting time at Aurinia and its commitment to its patients. The PV Science Lead will inaugurate and lead the newly formed GPS pillar of Pharmacovigilance Medical/Science and serve on the GPS leadership team along with heads of GPS Operations and GPS Compliance /Alliance.

PRIMARY RESPONSIBILITIES

• Develop strategies, working with the VP, GPS, to achieve PV Medical Safety goals.
• Coordinates, leads and communicates, all aspects of signal detection and safety review activities, as appropriate, to Aurinia GPS leadership including playing a critical role in the GPS signal detection and escalation process.
• Contributes to the development and execution of qualitative and quantitative safety surveillance strategies for the company’s development and marketed products.
• Identifies, validates, prioritizes, and performs an assessment on safety signals.
• Oversees and coordinates contributions of Medical Safety team with respect to study protocols, Investigator Brochures, and other safety-related documents / communications and oversees the clinical and scientific content of periodic safety reports (PADER, PBRER, DSUR).
• Supports GPS physician in overseeing the medical safety profile for assigned products.
• Provides functional and therapeutic area expertise in helping to manage the cross-functional assessment of benefit-risk profile and communication of safety information for assigned compounds and products.
• Facilitates ongoing safety surveillance for assigned products, working together with GPS Operations leadership and team.
• Formulates response strategies for health authority requests.
• Accountable for medical evaluation/interpretation of aggregate safety data of assigned product(s) including signal detection and evaluation, regulatory safety reports (PADER, PBRER/PSUR) and ad hoc safety assessments.
• Leads development and execution of risk management plans including implementation, and evaluation of their effectiveness.
• Contributes to safety-related justification documents to support the company’s position regarding labeling (CCSI, local product label, investigator’s brochure).
• Contributes to ad hoc safety analyses in response to health authority, DSMB, and Ethics Committee/IRB queries.
• Participates in cross-functional teams as a PV representative on clinical teams including working in collaboration with GPS MS and GPS Operations team, AE coding, all safety related documentation in start up and close phases of study.
• Presents proposals and plans to a variety of audiences, which could include the company’s senior executive team.
• Contributes to the training, leadership and continuing education for department staff.

 

Minimum Qualifications:
• A minimum of 10 years of relevant drug safety experience in the biotechnology/pharmaceutical industry, including a minimum of 5 years of safety leadership experience.
• In depth understanding of medical terminology.
• In depth knowledge of global clinical safety regulations, guidances, and reporting processes.
• Experience with MedDRA coding and safety database systems.
• Proficient in the Office suite of programs (Word, Excel, Power Point).

Required Competencies:

• Detail-orientation.
• 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.

Desirable Experience:

• 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 your information will be kept confidential according to EEO guidelines.