Boston, MA, USA | Real Staffing
Industry:HR / Recruitment Services
Job Description:84 people have viewed this job
Review and analyze the safety data from post-marketing sources and from clinical trials, the identification and investigation of safety signals, management of benefit-risk profile for assigned compounds and products.
The successful candidate will demonstrate the flexibility and capability to function at a high level across multiple disease areas and will be comfortable working in an entrepreneurial environment to advance the safety and biological understanding of compounds through life cycle. The individual who assumes this position will interact with multiple levels of management within, external stakeholders in the medical community as well with global regulatory authorities.
Manage safety surveillance for assigned compounds / products
Manage collection, in cooperation with a PV scientist, of current data for safety signaling and identify and investigate safety signals.
Conduct analysis of safety data.
Ensure adequacy of recording, summarizing, and handling of adverse events for investigational and/or marketed products including decisions on seriousness, expectedness, and causality.
Provide safety strategic leadership for clinical development programs / program teams
Integrate the safety scientific component to build a strategic framework for clinical development plans.
Develop and maintain relationships with program counterparts in Clinical Development, Pre-Clinical Safety, Research, Regulatory, Clinical Operations, Clinical Pharmacology, Quantitative Sciences, Translational Sciences, Worldwide Medical.
Ensure the accurate and timely completion and reporting of periodic and expedited safety reports, in compliance with internal time frames and time frames dictated by regulatory authorities.
If applicable, manage Associate Medical Director(s) overseeing their activities for assigned compounds/products.
Minimum 7 years' experience in the pharmaceutical industry or clinical care setting.
Preferably has prior experience in pharmacovigilance or clinical development.
Knowledge of pre- and post- marketing US and EU regulations
Knowledge of clinical epidemiology/biostatistics or clinical pharmacology highly desirable.
Capacity and willingness to work effectively across disease areas.
MD, or MD PhD, or MD MPH required, sub specialty training highly desirable
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