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Reporting to the chief medical officer, the drug safety physician will develop and lead the Drug Safety Department in designing, planning, and implementing safety monitoring procedures for all clinical programs and contribute to the design of protocols for drugs in all phases of development. The Drug Safety Department is dedicated to detecting any signals of safety issues and to managing safety risks in all Ironwood products. The Drug Safety Department will be responsible for medical assessment and processing of serious adverse event reports, generation/review of aggregate reports, signal evaluation, pharmacovigilance, risk management, and risk communication for Ironwood development and commercial products. The drug safety physician will be responsible for assessing the safety of our investigational and marketed products, thereby protecting the health of patients and contributing to the success of Ironwood products and our business.
- Develop safety strategies for Ironwood's compounds during their product lifespan from first-in-human studies through licensing and marketing;
- Manage safety risks of all Ironwood development and commercial compounds, throughout their life-cycle; review and interpret safety data to detect potential safety signals and propose labeling strategies;
- Serve as core member, representing the Drug Safety Department (or, as the department grows, delegate such membership) on the clinical development teams with responsibility for identifying and tracking safety issues. Provide input to our cross-functional teams who manage the life-cycle of our products;
- Perform medical review of all adverse event reports for seriousness, expectedness, and causality; generate pharmacovigilance comments;
- Assess the ongoing safety of Ironwood clinical trials and manage serious adverse event reports from clinical trials to identify and critically evaluate any signals of safety issues;
- Generate and maintain the safety content of clinical protocols, clinical study reports, investigators brochures, annual safety reports, core data sheets, and product labels;
- Lead the planning and implementation of pharmacovigilance and risk management strategies for submission to the regulatory authorities, lead development of the Integrated Summary of Safety for any NDA/MAA submissions, contribute to other regulatory submissions, and represent Ironwood at meetings with the regulatory authorities;
- Liaise with other parties such as licensing or co-development partners and consultants and contribute to preparations for Drug Safety Monitoring Boards. Respond to safety queries from colleagues in other internal departments;
- Manage all pharmacovigilance and risk management activities, including ongoing review of literature and compilation and interpretation of safety data to support product strategies;
- Lecture and train on safety issues at investigator meetings, staff training and informational sessions, and other venues as needed;
- Hire and lead drug safety associates on collection, processing, and obtaining follow-up information for individual case reports and provide guidance on coding and ranking of adverse events;
- Provide or supervise input to Analysis of Similar Events and aggregate reporting when necessary; review and approve Investigator Safety Letters;
- Respond to health authorities' queries, including addressing questions regarding safety reporting during health authority inspections;
- Provide input to the safety content of medical marketing communication materials;
- Represent Drug Safety on due diligence teams, generate due diligence reports, and contribute to final review processes;
- Participate in development and maintenance of SOPs and WDs related to medical aspects within the department;
- Work in compliance with relevant regulations, guidelines, and internal SOPs.
- Medically qualified with an M.D. or equivalent;
- Medical expertise in internal medicine (board certification or eligibility and subspecialty training would be a plus, but is not required);
- Minimum of 8 years of pharmaceutical/biotechnology industry experience with at least 5 years in drug safety;
- A good knowledge of pharmacovigilance practices, particularly in relation to signal detection and evaluation and risk management, and of the regulatory requirements relating to pharmacovigilance in the U.S. and internationally;
- Working knowledge of MedDRA;
- Strategic and analytical thinker with the ability to plan and design effective pharmacovigilance and risk management strategies;
- Ability to lead a team of functional experts and negotiate the multi-disciplinary environment in which they operate;
- Excellent written and verbal communication skills and good negotiating and influencing skills;
- Self-motivated, strong ability to prioritize and plan important work effectively;
- Available for domestic and international travel. | | | |
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