Senior Director/Director Global Patient Safety Physician

Description

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

• 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.

• 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

• Physician with proven clinical ability exercising medical judgment as a physician
• Fluent in written and spoken English

• 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

• 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