GPS Global Safety Physician

Ironwood Pharmaceuticals is a leading global gastrointestinal (GI) healthcare company on a mission to advance the treatment of GI diseases and redefine the standard of care for GI patients. We are pioneers in the development of LINZESS (linaclotide), the U.S. branded prescription market leader for adults with irritable bowel syndrome with constipation or chronic idiopathic constipation. Ironwood is also advancing apraglutide, a next-generation, long-acting synthetic GLP-2 analog being developed for rare gastrointestinal diseases, including short bowel syndrome with intestinal failure, as well as several earlier stage assets. Building upon our history of GI innovation, we keep patients at the heart of our R&D and commercialization efforts to reduce the burden of GI diseases and address significant unmet needs.Position Summary:The Global Safety Physician (GSP) is a leadership role within the Global Patient Safety organization accountable for executing the safety and risk management activities for clinical development and marketed products to enable the safe and effective use of Ironwood’s products by patients and healthcare providers. The GSP represents the medical safety function in relevant business processes and committees, both in clinical development and in the postmarketing space, to ensure consistency of safety focus, methods, and communications. This includes working closely with colleagues within the GPS Medical Risk Management team (MRM) and cross-functional teams to provide internal safety representation to the development teams, conduct review of partner scientific & medical deliverables, and other activities associated with structured benefit risk assessment of assigned assets.Responsibilities:Oversight of the medical review of individual adverse event reports for Ironwood products, both from clinical trials and post-marketing, for seriousness, expectedness, and causality, adhering to documented procedures and company/vendor timelines.Oversight of and close collaboration with the MRM team for various safety-related activities.Lead and/or participate in the identification and assessment of potential safety signals for Ironwood products and communication to the relevant safety governance bodies.Provide medical interpretation of information from various sources to inform the safety profile of Ironwood products, such as clinical trial and postmarketing adverse events and safety information, nonclinical and toxicology information, scientific literature, and product quality complaints.Lead and/or participate in development and maintenance of risk management plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS), as needed.Collaborate with Business Partners on the exchange of safety data, safety monitoring and safety profiles, as laid out in Pharmacovigilance Agreements.Provide consultation for medically related questions from participating vendors, Partners, etc.Lead the medical safety strategy and/or draft safety sections for aggregate reports (e.g., DSUR, PBRER/PSUR, PADER), regulatory requests, and signal assessments, as necessary.Provide medical safety input for Investigator's Brochures (IBs), protocols, Case Report Forms (CRFs), IND and NDA submissions, Product Labels, Annual Safety Reports, and other regulatory documents and communications.Provide clinical and strategic input to the design of clinical trials, signal refinement/validation activities, post authorization studies, risk minimization, and risk communication.Lead, contribute, and/or review of safety related deliverables for marketing applications such as ISS, SCS, CO, nonclinical overview, and patient narratives.Responsible for development of documents and for negotiation with Regulatory Authorities on safety matters involving Ironwood products.Integrate concepts and guidelines from FDA, EMA and other regulatory agencies, public health agencies and nongovernmental organizations, and clinical practice groups.Contribute expertise in medical safety and pharmacoepidemiology to the development and maintenance of Pharmacovigilance Analytics systems and processes.Closely collaborate with Clinical Operations, GPS Operations, Regulatory Affairs, and applicable vendors for seamless PV processes.Qualifications:Medical degree required or internationally recognized equivalent.Minimum of 8-10 years of experience in pharmacovigilance, ideally within both postmarket and clinical safety.Excellent written and communication skills, with demonstrated ability to communicate complex medical information to a variety of audiences.Experience with regulatory agencies and key stakeholder interactions.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 US and internationally.Excellent analytical, problem-solving, strategic planning, and interpersonal skills.Familiarity with quantitative methods.Proficiency in statistics, epidemiology, MedDRA coding, Microsoft Excel, Word, and PowerPoint; ability to learn new computer systems as they are implemented.Demonstrated project leadership around pharmacovigilance activities with cross-functional teams in a multicultural environment.Ironwood Pharmaceuticals is an equal opportunity employer welcoming diversity in our workforce.

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