Reporting to the Executive Medical Director & Head of PSS Medical, the incumbent will be largely responsible for the medical review of serious adverse events derived from clinical trials, in support of drug safety activities for clients.
Essential Job Duties:
- Responsible for medical review of serious adverse events and adverse events of special interest from Clinical Trials in support of safety activities for clients.
- Develops new and enhances existing client relationships whenever possible
- Provides medical/safety expertise to colleagues within PSS&A;, including communicating information regarding safety regulations and any changes that have occurred
- When applicable,
responsible for preparation and medical review of Aggregate Reports (such as Periodic Adverse Drug Experience Reports – PADERs) required by global regulatory agencies for review of safety information for assigned products.
- When applicable, responsible for medical review of serious adverse events and nonserious adverse events from spontaneous reports and reports derived from regulatory authorities and the medical literature during postmarketing surveillance in support of safety activities.
- When applicable, responsible for signal detection and evaluation activities and preparation and submission of Ad Hoc Reports reviewing specific safety issues to the global regulatory agencies for assigned products.
- Full Japanese language fluency; both written and spoken
- MD or DO with at least one year of postgraduate training or equivalent, having substantial knowledge of drug / device safety and the underpinning global regulations
- MD who has completed an accredited residency program or equivalent and is board eligible or certified with at least 4 years’ experience is highly preferred
- Minimum of 5 years experience working as a Safety Physician (or in an equivalent specialist role) within a pharmaceutical company, health authority or contract research organization