Senior Director/Director Global Patient Safety Physician

Aurinia Pharmaceuticals Inc.; Rockville (MD); On-site; USD 125,000 - 209,000; Full time

Job summary

Aurinia Pharmaceuticals Inc. seeks a Senior Director/Director of Global Patient Safety to oversee pharmacovigilance efforts, ensuring rigorous safety and regulatory compliance for their innovative drug portfolio. The role requires a seasoned medical professional committed to transforming the lives of patients with autoimmune diseases and adept in safety data analysis and risk management.

Qualifications

• Physician with comprehensive experience in pharmacovigilance (5-10 years).
• Solid knowledge of regulatory submissions and legislation.
• Fluency in English.

Responsibilities

• Lead pharmacovigilance medical activities and ensure safety assessments.
• Support clinical trial safety and regulatory submissions.
• Contribute to risk management strategies and safety evaluations.

Skills

Medical judgment

Networking

Problem-solving

Communication skills

Education

Medical doctor (MD)

Job description

Senior Director/Director Global Patient Safety Physician

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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

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