- Responsible for medical review of serious adverse events and adverse events of special interest from clinical trials in support of drug safety activities for clients.
- When applicable, responsible for preparation and medical review of Aggregate Reports required by global regulatory agencies for review of safety information for assigned products, when authorized to perform this function on behalf of a client.
- 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, when authorized to perform this function on behalf of a client.
- Participates in training opportunities to advance knowledge of pharmacovigilance as it relates to drug/product development and drug/product marketing utilizing good clinical practice guidelines
- Provides medical/safety expertise to project teams, including communicating information regarding drug safety regulations and any changes that have occurred
- Reviews laboratory values, adverse events, coding dictionaries and data tables, listings and figures as needed to identify drug safety issues in collaboration with the project physician
- Assists in the preparation of pharmacovigilance materials for investigator meetings
- Provides pharmacovigilance support to project physicians, as appropriate
- Responsible for medical and safety monitoring on assigned projects
MD with at least one year of postgraduate training or equivalent.
MD who has completed an accredited residency program or equivalent and is board-eligible or certified with at least 4 years experience with substantial knowledge of drug safety and the global regulations governing pharmacovigilance and risk management
At least 10 years of experience working either for a pharmaceutical company, health authority or a contract research organization in related fields such as QA, Regulatory Affairs, medical writing, PCS, TM or clinical medical monitoring
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