*This position can be remote*
This position partners with cross functional stakeholders in support of the product safety profile and benefit risk throughout product lifecycle through signal detection, signal evaluation, and preparation of written and verbal summaries of signal management activities and risks to patient safety to present to senior management and regulatory authorities globally.
- Responsible for standard surveillance activities for a product’s life cycle (one or more assigned compounds and products) through review of safety data from clinical trials, safety databases, and the literature.
- Collaborates with safety and clinical teams to develop strategies and approaches for signal assessments and regulatory requests by analyzing data from multiple sources. Independently analyzes data for signal assessment and leads preparation of materials of ad hoc regulatory safety requests using data from multiple sources.
- Utilizes medical judgment to determine the impact of the safety issue on the product’s benefit-risk profile. Communicates findings of surveillance activities and safety assessments to product teams and leadership to inform on necessary risk minimization activities, including label changes.
- Collaborative preparation and maintenance of safety sections of Clinical Summary of Safety, Clinical Study Reports, Company Core Data Sheets and Risk Management Plan. Independently authors, strategizes and reviews global aggregate safety reports in accordance with regulatory requirements and standard operating procedures
- Independently prepares summaries of key safety data for PST, SRB, senior management, Advisory and other similar meetings Partners to lead safety-related activities/initiatives internal to PPS.
- Proficient in pharmacovigilance regulations, guidelines, and company standard operating procedures In depth understanding of compounds within assigned therapeutic areas, including safety profile and where applicable, labeling, literature, clinical and regulatory issues. Mentors and trains new safety scientists
- Degree in a Health Sciences (e.g., Pharmacy, Epidemiology, Nursing); o Bachelors + 4 years clinical/pharma or safety work experience o Masters or doctorate + 2 years clinical/pharma or safety work experience (e.g. MPH, PharmD, PhD, or Masters in a Health Science)
- Knowledge of the drug development process which includes conducting clinical trials, scientific strategy and operations management for the planning, execution and reporting of clinical development programs, regulatory requirements for submission, product launch and post marketing support. Demonstrates ability to connect regulatory obligations and safety science to support safety decision making.
- Understanding of tools, standards and approaches used to efficiently evaluate drug safety is desirable. Serves as a resource to cross-functional colleagues by soliciting input and providing recommendations and conclusions. Demonstrates effectiveness in working in a multidisciplinary, matrix team situation. Demonstrates effectiveness in working in a multidisciplinary, matrix team situation
- Effective oral and written communication skills with the ability to manage multiple projects simultaneously . Microsoft WORD and EXCEL skills and Basic Project Management skills. Able to work independently with minimal direct supervision.
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Job Type: Experienced