healthcare
Posted Apr 23Associate Medical Director / Safety Physician
at Fortrea
Shanghai, ChinaRemote
Responsibilities
- Responsible for medical review of serious adverse events and adverse events of special interest from Clinical Trials in support of safety activities for clients.
Requirements
- Qualifications (Minimum Required): 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.
- Fortrea may consider relevant and equivalent
- experience in lieu of educational requirements.
- experience working for a pharmaceutical company, health authority or a contract research organization in Safety or related fields such as QA, Regulatory Affairs, medical writing, or clinical medical monitoring. Preferred
- Qualifications Include: MD who has completed an accredited residency program or equivalent and is board-eligible or certified with at least 4 years’ experience.
Additional details
- Job Overview: Provide medical safety expertise, directly and indirectly, to Sponsors undertaking clinical trials of drugs, devices, and combination products, and in the post marketing period. Summary of
- Develops new and enhances existing client relationships whenever possible.
- Provides medical/safety expertise to colleagues within PSS, 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.
- Provides safety support/expertise to project physicians, as appropriate.
- Presents Safety capabilities to clients as part of a proposal team, when appropriate.
- When applicable, responsible for medical review of serious adverse events and non-serious adverse events from spontaneous reports and reports derived from regulatory authorities and the medical literature during post marketing surveillance in support of safety activities.