Sr Mgr, GPS Safety Sciences

Senior Manager, GPS Safety Sciences Remote, NJ The Temp - GPS Safety Scientist will play a key scientific role in safety strategies for molecules in clinical development and post-marketing phases for our Internal Medicine Therapeutic Area. We will expect this to include safety data aggregation, review, and analysis to support appropriate safety interpretation and benefit-risk assessment. In this role, a typical day might include the following: Complete signal detection activities in line with approved safety surveillance plan. Perform signal evaluation for any identified signals and author the safety evaluation reports. Manage preparation and review of safety documents including DSUR, PSUR, RMP, response to health authority or other queries. Prepare and deliver presentations at Signal Management Team (SMT) meetings; participate in clinical study team meetings for assigned compounds. Participate in other risk management activities as appropriate for assigned compounds. We may ask you to represent GPS on cross-functional teams, including company’s Safety Oversight Committee, Independent Data Monitoring Committees (IDMC) and other teams with members external to company. Requirements: Ability to apply relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments. Ability to work with a safety system database for purposes of medical case review and simple queries. Able to be proactive and self-disciplined, you can meet deliverables and effectively use your time and prioritize. Ability to effectively communicate (verbal and written) safety findings. Previous safety or relevant clinical experience in the pharmaceutical industry required, typically with at least 5 years of risk management or relevant clinical experience in pharmaceutical/ biotech industry or health authority. Clinical experience and/or industry experience in the TA of interest is a plus. To be considered for this opportunity, you must have a Master's, PhD, or PharmD with 5+ years of relevant risk management experience in the pharmaceutical/ biotech industry or health authority. Actively participate in process improvement initiatives e.g., the development and maintenance of relevant SOPs, WIs and supporting documents. Please contact Darren Gutowski at [email protected] Apply tot his job Apply To this Job