Responsibilities will include:
- Signal detection, evaluation, and management from clinical trials
- Search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection and write up analysis results
- Collaborate with other functional area, including but not limited to Biostatistics, Clinical, Translational Sciences, Research and Regulatory Affairs to identify, evaluate, understand and risk manage safety signals.
- Participate in the authoring of relevant safety sections of clinical protocols, Investigator's Brochure (IB), informed consent form (ICF), statistical analysis plans, study reports and other clinical study-related documents to ensure alignment with the safety strategy and risk communication.
- Author and review aggregate reports e.g. (DSUR) in collaboration with the aggregate report writers.
- Participate in the development of safety-related data collection forms for clinical studies and ensure consistency in safety data collection
- Contribute to health authority and other safety related query responses including literature searches
- Collaborate in the planning for and creation of an effective signal tracking process that fully documents signaling activities and can be used for regulatory inspection
- Provide leadership in the development, implementation, and maintenance of robust procedures for the planning, preparation, and submission of high-quality safety reports
- Medical review of individual case safety reports (ICSRs) in a timely manner to ensure on time submission to regulatory authority.
Skills and Qualifications:
- This is typically a role best suited to a PhD, RN, PharmD or MD with a minimum of 5 years’ experience in Pharmacovigilance who possesses:
- Experience working on oncology trials, ideally cellular therapies
- Experience in IND applications and early development
- Expertise in US and international regulations governing drug safety
- Experience in signal detection, evaluation, aggregate data analysis, and interpretation in clinical trials.