This listing was posted on Tip Top Job.
Director, Safety Physician : Remote
Location:
Gaithersburg, MD
Description:
We go where others won't, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world.Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed:to protect and enhance life. JOB SUMMARYThis position is responsible for overseeing the activities of the Global Patient Safety and Epidemiology function and ensuring corporate compliance with all applicable US and foreign legal and regulatory requirements for adverse event reporting and safety management of medicinal products, both approved and in development. The Director, Safety Physician provides medical and/or operational assessments of all Patient Safety issues in all phases of clinical trials and post:marketed reports to ensure subject safety and accurate interpretation of results. This position will report to the Sr. Medical Director, Medical Safety Evaluation and Strategy. ESSENTIAL FUNCTIONSReasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. - Assess and oversee the activities for monitoring adverse event reports for potential drug:safety related issues and provides recommendations when potential issues are identified.- Collaborate with Clinical Research and Development and Medical Affairs and applicable functional specialists to identify, evaluate and manage safety signals.- Lead signal management, safety surveillance and risk management plans for drug development programs and post:marketed products.- Chair the Safety Review Team.- Collaborate with safety scientists to prepare expedited and aggregate safety reports (e.g., 15:day Alert Report, SUSAR, PSUR, US PADER, Annual Safety Report, DSUR, IND Annual Report, etc.).- Provide expert functional advice as well as assistance to other functions as needed.- Review, update, or write company SOPs related to Pharmacovigilance and safety reporting to ensure their compliance with EMA, ICH, and FDA guidelines.- Assist in the preparation and review of safety section(s) of investigator brochures, protocols informed consent forms, statistical analysis plans, clinical study reports, NDA/BLA/CTD submissions and other documents.- Provide medical expertise and contributions to pharmacovigilance activities and priorities such as: Ad:hoc safety information/reports for inquiry response to Regulatory Health Authorities safety queries as well as from senior management including safety documentation for licensure submissions.- Prepare Company Core Safety Information (CCSI) for marketed and investigational products and the Company Core Data Sheet (CCDS),- Lead the determination of Adverse Reactions section of the product label; leads and support the preparation and review of other safety relevant sections of the label.- Facilitate and ensures communication with departments that may be involved with receiving, investigating, or reporting AEs.- Collaborate with and provides pharmacovigilance guidance and support for interdepartmental and/or corporate initiatives.- Collaborate with corporate partners to ensure proper exchange of drug:safety data.- Responsible for case reports (clinical trials and post marketing) submission to Regulatory Authorities in a timely manner.- Assist Data Management with MedDRA and WHO dictionary codes and other medical perspective.- Review of the case information entered in the safety database to ensure quality and accuracy of the data entered (i.e., updates and corrects MedDRA and WHO dictionary codes).- Completes the Company Medical Assessment for ICSR. The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsib
Industry:
Legal
Posted:
May 7 on Tip Top Job
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More About this Listing: Director, Safety Physician : Remote
Director, Safety Physician : Remote is a Nurse & Healthcare Physician Job located in Gaithersburg MD. Find other listings like Director, Safety Physician : Remote by searching Oodle for Nurse & Healthcare Physician Jobs.
Director, Safety Physician : Remote is a Nurse & Healthcare Physician Job located in Gaithersburg MD. Find other listings like Director, Safety Physician : Remote by searching Oodle for Nurse & Healthcare Physician Jobs.