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Data: 07/06/2013
Novartis Italia ricerca: Benefit Risk Physician.
The ideal candidate will:
• Write BRM project plans and work with the Risk Management Leader to schedule meetings, establish timelines, assign tasks, track issues and assure completion of action items.
• Develop procedures that address the management of safety information to ensure proactive surveillance of assigned NV&D products.
• Forge effective working relationships with medical leaders in Clinical Development and Med-ical Affairs, as well as their counterparts at partner companies.
• Serve as safety expert on the GPT.
• Integrate, analyse and interpret safety information from all sources, including preclinical through lifecycle management (post-approval) and externally.
• Provide integrated safety input in all documents required during drug development, including CDP, study protocols, informed consents, Investigator Brochure, Annual Safety Reports, Core Data Sheet, Summary of Clinical Safety, Clinical Overview.
• Assist with Regulatory Agencies inspections within Pharmacovigilance and ensure timely submission of aggregate reports.
• Work with the Regional Physicians in the review and assessment analytical plans to evaluate safety issues and leverage necessary resources to respond to safety related issues and inquries.
• Respond to ad hoc safety queries from the Health Authorities, through the responsible RA Manager.
• Working with the signaling team, identifie, analyse, assesse, and communicate new safety signals based on safety escalation process and presents at milestone and/or annually the integrated safety data for products in full development at the Safety Committee and other decision boards, as required.
• Take lead in the development and updating of SPP and Safety RMP documents and safety section of CDP.
• Propose pharmacovigilance activities in alignment with the Safety RMP strategy.
• Ensure alignment between Safety Profiling Plan (SPP), Summary of Clinical Safety (SCS), Clinical Development Plan (CDP), and if marketed, with safety section of label, Safety RMP and Periodic Safety Update Report (PSUR).
• Present final version of SPP and Safety RMP to Safety Committee and if appropriate, to the CPT/IB and/or PSB and obtains appropriate approvals.
• Ensure communication of safety information and all relevant safety documents to EU QPPV, as appropriate.
• Cooperate with the Product Recall Committee in case of suspected quality problems with possible medical consequences
• Identify and analyse safety signals based on a comprehensive evaluation of postmarketing data and Serious Adverse Events (SAEs) from clinical trials.
• Oversee single case assessments, especially for key events.
• Report on status and progress of Safety RMP commitments in the PSUR.
• Co-author PSURs, Bridging and Addendum Reports together with the assigned PV physician.
• Review Investigator Notifications and releases SUSAR listings.
• Be responsible for routine ongoing review of all clinical trial data including safety data and la-boratory data during the course of a clinical trial.
Novartis is an Equal Opportunity Employer.
Minimum requirements:
• MD from accredited medical school. Active license to practice medicine + board certification.
• Excellent knowledge of written and spoken English.
• 5+ years of experience in clinical trial safety and risk management is required, including substantive experience in clinical trial safety and all aspects of risk management (risk identification; risk assessment; risk communication; risk mitigation; evaluation of risk mitigation).
• Exposure to clinical development and/or clinical safety of at least 1 product submitted to regulatory authorities for marketing authorization. Understanding or current approaches to balancing the benefits and risks of pharma products and / or vaccines.
• In particular, experience developing and implementing a risk management plan that was accepted by the FDA or EMEA.
• Familiarity with cross functional principles of drug development, pharmacology, biostatistics, clinical trial methodology, pharmacoepidemiology, medical safety and pharmacovigilance.
• Comprehensive knowledge of global drug safety regulations, guidelines, guidances and best practices is required.
• Excellent communication skills, including formal presentation skills.
• Ability to thrive in a global, matrix environment as a team player.
• Ability to successfully manage and prioritize multiple critical issues simultaneously.
• Maintain a high degree of independence with respect to decision making and problem solving, adjusting rapidly to changing priorities, and working well under pressure.
Country: Italy.
Work Location: Siena.
Job Type: Full Time.
Employment Type: Regular.
Per ulteriori informazioni potete consultare il seguente link.
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