Aurinia Pharmaceuticals Inc.
Senior Director/Director Global Patient Safety Physician
Aurinia Pharmaceuticals Inc., Rockville, Maryland, us, 20849
Senior Director/Director Global Patient Safety Physician
Join to apply for the
Senior Director/Director Global Patient Safety Physician
role at
Aurinia Pharmaceuticals Inc. Senior Director/Director Global Patient Safety Physician
3 days ago Be among the first 25 applicants Join to apply for the
Senior Director/Director Global Patient Safety Physician
role at
Aurinia Pharmaceuticals Inc. Get AI-powered advice on this job and more exclusive features. Description
Changing the trajectory of autoimmune diseases.
Enabling patients to live their fullest life.
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.
Skills
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
This role will provide a unique opportunity for the right candidate to combine their clinical trial and post-marketing medical Pharmacovigilance (PV) knowledge with proven PV science and safety signaling expertise Small, well-established and experienced Global Patient Safety (GPS) team responsible for comprehensive end to end Pharmacovigilance support of active clinical trials, global post-marketing / spontaneous surveillance and on-going benefit/risk assessments Support the risk management activities for the respective products, ensuring high quality medical safety input for all benefit- risk assessments.
This requires effective medical, technical, and scientific expertise in safety data collection, evaluation, medical interpretation and communication and global PV regulations and guidances.
Responsibilities
Support of and active member of PV Operations team / medical case reviews on behalf of Aurinia GPS Lead Aurinia’s PV medical activities including but not limited to: Clinical trial support (safety/risk sections of ICF, IB, protocols, iDMCs and meeting attendance) Post-market signal activities including signal detection and signal evaluation activities for assigned products Aggregate and periodic safety reports (PSURs, PBRERs, DSURs) Deliver medical safety assessments as required, e.g. in the evaluation of the risk and impact of product quality complaints, health hazard assessment as required Support of medical information inquiries and publications Ensure that clinical development plans/life-cycle management plans adequately address the safety questions and deliver the safety strategy Ensure that all safety-based decisions for benefit-risk assessment are taken in the knowledge of a comprehensive assessment of all available data Serve as primary Aurinia GPS Lead in the development of the Risk Management Plan for assigned products, as applicable Provide therapeutic and product-specific training within GPS and more widely within the company and for external vendors as required Provide medical support (and project leadership as delegated by the Head of GPS) for all safety components of regulatory submissions, health authority safety-related questions Provide relevant subject matter expertise as required for audits and inspections, including any necessary pre[1]work in preparation for the audit/inspection, interviews with auditors/inspectors, as required, and follow-up on any subsequent actions and CAPAs Ensure that the Head of GPS, and thereby Aurinia senior management, are kept informed of any new data that might impact the benefit risk of assigned Aurinia products Ensure up-to-date oversight of the emerging safety profile for all assigned Aurinia products As delegated by Head of GPS, provide medical safety expertise for due diligence activities, preparing an integrated safety assessment for consideration by senior management Contribute to the overall success of Global Patient Safety and Aurinia
Qualifications
Physician with proven clinical ability exercising medical judgment as a physician Fluent in written and spoken English
Ideal
Industry experience in pharmacovigilance (5-10 years) Knowledge of product development processes and experience of cross-functional teamwork Solid working knowledge of pharmacovigilance legislation Prior experience with NDA/BLA or equivalent regulatory submissions, or experience working in a Regulatory Agency reviewing submission file
Required Competencies
Competent medical judgment in safety decision-making Competent team player with excellent networking and influencing skills Ability to prioritize own workload, work under pressure and achieve strict timeline targets Excellent verbal and written communication skills Problem-solving approach – solution- and results-orientate
Additional Information
All candidate information will be kept confidential according to EEO guidelines. Seniority level
Seniority level Director Employment type
Employment type Full-time Job function
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Join to apply for the
Senior Director/Director Global Patient Safety Physician
role at
Aurinia Pharmaceuticals Inc. Senior Director/Director Global Patient Safety Physician
3 days ago Be among the first 25 applicants Join to apply for the
Senior Director/Director Global Patient Safety Physician
role at
Aurinia Pharmaceuticals Inc. Get AI-powered advice on this job and more exclusive features. Description
Changing the trajectory of autoimmune diseases.
Enabling patients to live their fullest life.
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.
Skills
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
This role will provide a unique opportunity for the right candidate to combine their clinical trial and post-marketing medical Pharmacovigilance (PV) knowledge with proven PV science and safety signaling expertise Small, well-established and experienced Global Patient Safety (GPS) team responsible for comprehensive end to end Pharmacovigilance support of active clinical trials, global post-marketing / spontaneous surveillance and on-going benefit/risk assessments Support the risk management activities for the respective products, ensuring high quality medical safety input for all benefit- risk assessments.
This requires effective medical, technical, and scientific expertise in safety data collection, evaluation, medical interpretation and communication and global PV regulations and guidances.
Responsibilities
Support of and active member of PV Operations team / medical case reviews on behalf of Aurinia GPS Lead Aurinia’s PV medical activities including but not limited to: Clinical trial support (safety/risk sections of ICF, IB, protocols, iDMCs and meeting attendance) Post-market signal activities including signal detection and signal evaluation activities for assigned products Aggregate and periodic safety reports (PSURs, PBRERs, DSURs) Deliver medical safety assessments as required, e.g. in the evaluation of the risk and impact of product quality complaints, health hazard assessment as required Support of medical information inquiries and publications Ensure that clinical development plans/life-cycle management plans adequately address the safety questions and deliver the safety strategy Ensure that all safety-based decisions for benefit-risk assessment are taken in the knowledge of a comprehensive assessment of all available data Serve as primary Aurinia GPS Lead in the development of the Risk Management Plan for assigned products, as applicable Provide therapeutic and product-specific training within GPS and more widely within the company and for external vendors as required Provide medical support (and project leadership as delegated by the Head of GPS) for all safety components of regulatory submissions, health authority safety-related questions Provide relevant subject matter expertise as required for audits and inspections, including any necessary pre[1]work in preparation for the audit/inspection, interviews with auditors/inspectors, as required, and follow-up on any subsequent actions and CAPAs Ensure that the Head of GPS, and thereby Aurinia senior management, are kept informed of any new data that might impact the benefit risk of assigned Aurinia products Ensure up-to-date oversight of the emerging safety profile for all assigned Aurinia products As delegated by Head of GPS, provide medical safety expertise for due diligence activities, preparing an integrated safety assessment for consideration by senior management Contribute to the overall success of Global Patient Safety and Aurinia
Qualifications
Physician with proven clinical ability exercising medical judgment as a physician Fluent in written and spoken English
Ideal
Industry experience in pharmacovigilance (5-10 years) Knowledge of product development processes and experience of cross-functional teamwork Solid working knowledge of pharmacovigilance legislation Prior experience with NDA/BLA or equivalent regulatory submissions, or experience working in a Regulatory Agency reviewing submission file
Required Competencies
Competent medical judgment in safety decision-making Competent team player with excellent networking and influencing skills Ability to prioritize own workload, work under pressure and achieve strict timeline targets Excellent verbal and written communication skills Problem-solving approach – solution- and results-orientate
Additional Information
All candidate information will be kept confidential according to EEO guidelines. Seniority level
Seniority level Director Employment type
Employment type Full-time Job function
Job function Other Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Aurinia Pharmaceuticals Inc. by 2x Get notified about new Senior Director/Director Global Patient Safety Physician jobs in
Rockville, MD . Washington, DC $125,049.60-$208,436.80 1 day ago District of Columbia, United States 17 hours ago Washington, DC $160,000.00-$180,000.00 1 week ago Washington, DC $160,000.00-$180,000.00 1 week ago District of Columbia, United States $179,000.00-$298,000.00 5 days ago Director, Healthcare Enterprise Strategy
District of Columbia, United States $179,000.00-$298,000.00 1 week ago Senior Director, Perioperative Business and Operations
Vice President, Community Health and Well-Being - Trinity Health Mid-Atlantic/Holy Cross Maryland
Senior Director, Turnkey Operations, Remote
Washington, DC $174,514.00-$180,583.00 1 month ago Arlington, VA $90,000.00-$105,000.00 1 week ago Director, Ambulatory Practice Transformation and Quality Performance
Director of Operations, Day Shift, Outpatient Imaging
Gaithersburg, MD $116,227.90-$174,341.84 4 months ago Forestville, MD $142,988.00-$151,567.00 1 week ago Vice President, Development, Mid-Atlantic/Northeast, USPI
Associate Vice President, Population Health Science
Director, Patient Access Program (PAP) Operations
Washington, DC $120,000.00-$160,000.00 1 month ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr