The objective of this position is to provide medical expertise in the assessment of safety data from a variety of postmarketing sources as part of the overall surveillance program for the products. This position leads the implementation of the Signal Management Group (SMG) surveillance strategies for proactive and systematic detection and the evaluation of new safety signals and emerging trends from post-marketing safety data. These activities include the use of novel, computer-assisted tools and statistical methodologies for signal detection in the internal company safety data, international regulatory safety databases, and other data sources, e.g. claims and electronic medical records.
- The Signal Detection Physician also provides medical guidance to the Safety Management Teams in the completion of surveillance activities, analysis of safety data, and conclusions derived from these analyses.
- This position implements product-specific surveillance plans, performs signal detection activities, including signal validation, and participates in communication of emerging signals to the Medical Safety Officers and in forums such as the Safety Management Teams (SMTs).
- This position will also participate in the development of strategies for signal evaluation, including providing guidance on data sources and methods of analysis and may include performing activities supporting signal evaluation, such as ad hoc data mining of FDA FAERS, WHO Vigibase, and EMA EudraVigilance databases.
- Identify and assess new safety signals and trends by conducting systematic reviews of aggregate safety data, e.g. spontaneous and noninterventional adverse event reports.
- Perform signal detection activities in the Company safety platforms for products of responsibility, including SMART, routine and ad hoc data mining in Empirica Signal, and signal entry into Empirica Topics.
- Perform validation of safety signals identified in reviews. Prepare reviews of topics and summary analysis reports of safety data. Communicate findings to Medical Safety Officers and the SMTs. Provide recommendations for further evaluation.
- Perform aggregate surveillance of adverse event reports for potential product quality issues.
- Participate as member of the matrix teams to address product-specific safety issues.
- Assist in the development of signal evaluation strategies, including providing guidance on data sources and methods of analysis.
- Participate in signal evaluation, including case definition development, review of the signal tracking system, ad hoc data mining in FAERS, Vigibase, and SCEPTRE.
- Communicate findings from routine and ad hoc signal detection and assessment activities.
Education and Experience requirements
- A Physician (MD or equivalent), is required. A Board Certification (if US) is preferred.
- A minimum of 3 years of experience in industry, academia or patient care settings is required.
- Direct experience in pharmacovigilance is strongly preferred.
- Experience in clinical practice after postgraduate training program is preferred.
- Experience and knowledge of Good Clinical Practices is required.
- Knowledge of pharmacovigilance regulatory requirements in US, the EU and globally is strongly preferred.