Associate Director, Global Patient Safety

Description

Our Mission: Changing the trajectory of autoimmune diseases.
Our Vision: Enabling patients to live their fullest life.
We are a dedicated team of experts committed to changing the trajectory of autoimmune diseases with unmet medical needs. We are relentless in our pursuit to provide transformative medical treatments. We are resilient. We Care.
Along with driving adoption of our approved therapy, LUPKYNIS™, for appropriate people with lupus nephritis, we are pursuing a broader portfolio of innovative autoimmune disease therapies.
We provide high quality products to our patients, that are safe and effective. Each of us at Aurinia own Quality, and we proactively integrate Quality into everything that we do. Exceptional quality and regulatory compliance are essential to our business, and “We Care” so that patients can take our drugs with confidence.
Our strategy leverages the skills and knowledge of our expert team and our deep experience in principled drug development and commercialization. Aurinia’s working environment enables every individual to thrive in a professional atmosphere guided by our Culture Values:

• Achieve together
• Collaborate
• Explore & build
• Act responsibly

Together, we drive to change the trajectory of autoimmune disease for patients in need.
Overview
Aurinia is seeking a talented Pharmacovigilance Professional to join our growing GPS team at this critical and exciting time at Aurinia and its commitment to its patients. The Associate Director in Global Patient Safety will join the dynamic GPS pillar of Pharmacovigilance Medical/Science and collaborate and represent PV Medical/Science team with members of the GPS Operations and GPS Compliance/Alliance teams.
Responsibilities:

• Develop strategies, working with the VP, GPS, to achieve Associate Director, Global Patient Safety, PV Medical Safety goals.
• Coordinates, contributes and communicates, all aspects of signal detection and safety review activities, as appropriate, to Aurinia GPS leadership including playing a central role in the GPS signal detection and escalation process.
• Identifies, validates, prioritizes, and performs an assessment on safety signals.
• Works with 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.
• Responsible for GPS Medical/Science documentation including meeting agends/minutes, slide presentation creation, etc.
• Provides functional expertise in helping to manage the cross- functional assessment of benefit-risk profile and communication of safety information for assigned compounds and products.
• Serve as SPOC for Medical Safety Team during audits/inspections as appropriate per agenda topic
• Facilitates ongoing safety surveillance for assigned products, working together with GPS Operations team.
• Facilitates and collaborates 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.
• Assists with the 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.
• Contributes and reviews/updates/creates role relevant process documents
• 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.

Qualifications:
Minimum Qualifications:

• A minimum of 5 years of relevant drug safety experience in the biotechnology/pharmaceutical industry, including a minimum of 3-4 years of direct PV Science experience.
• In depth understanding of medical terminology.
• In depth knowledge of global clinical safety regulations, guidance, 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.

Additional Information
All candidate information will be kept confidential according to EEO guidelines.