Functional area: DSPV
With an exciting pipeline, and a growing number of products on the market, Ironwood is hiring a Drug Safety Physician to strengthen the Medical Safety team. The Drug Safety Physician is responsible for safety surveillance of assigned products. This implies medical assessment of adverse event reports, detecting and assessing safety signals and proposing risk mitigating activities. With that aim, the Drug Safety Physician 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. The role of the Drug Safety Physician is a global one and involves collaboration with business partners that hold licenses in other global regions.
- Medically review individual adverse event reports with assigned products, both from clinical trials and post-marketing, for seriousness, expectedness and causality.
- Identify and assess potential safety signals for Ironwood products and communicate to the Safety Review Committee.
- Collaborate with Business Partners, on the exchange of safety data, safety monitoring and safety profile, as laid out in Pharmacovigilance Agreements.
- Draft Analysis of Similar Events for SUSARs, and aggregate reports as necessary; review and approve Investigator Safety Letters.
- Draft Development Safety Update Reports (DSURs) and Post-Marketing Periodic Safety Updates (PSURs) as necessary.
- Provide medical safety input for Investigator's Brochures, IND and NDA submissions, Product Labels, MAA Annual Safety Reports and other regulatory documents and communications.
- Review and approve safety sections of clinical trial protocols, analysis plans, study reports.
- Closely collaborate with Clinical Operations, Safety Operations and Regulatory Affairs for seamless PV processes.
- Collaborate with clinical trial directors for safety monitoring.
- Medically qualified with an MD or equivalent
- Medical expertise in internal medicine
- Minimum of 3 years industry experience; 2 years of clinical practice
- 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
- Working knowledge of MedDRA
- Board certification or eligibility and subspecialty training would be a plus but is not required
- Be familiar with quantitative methods, experience in epidemiology is a plus