Planet Pharma Cambridge , MA 02138
Responsible for global pharmacovigilance for marketed and/or investigational products, including review and analysis of 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. Responsible for keeping upper management informed of safety issues and may work with clinical programs as medical advisor. May represent Safety and Benefit Risk Management at internal and external meetings. The successful candidate will demonstrate the flexibility and capability to function 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 client, external stakeholders in the medical community as well with global regulatory authorities.
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.
Minimum 3 years experience in the pharmaceutical industry, clinical care setting, or Academia.
Industry experience in early clinical development is highly desirable.
Benefit-risk related strategy experience required.
Knowledge of clinical pharmacology and pre-clinical safety highly desirable.
Demonstrated strategic and critical thinking.
Excellent communication skills (oral and written) and excellent organizational skills.
Capacity and willingness to work effectively across disease areas.
The ability to lead directly and by influence, including strong problem solving, conflict resolution, and analytical skills.
Demonstrated ability to work in an entrepreneurial culture