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 drug safety activities for clients.
Assumes responsibility for medical and safety monitoring on assigned projects
When applicable, responsible for preparation and medical review of Aggregate Reports (Periodic Safety Update Reports – PSURs, Periodic Adverse Drug Experience Reports – PADERs) required by global regulatory agencies for review of safety information 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
Provides pharmacovigilance support to project physicians, as appropriate
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
Participates in project risk assessment 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, when authorized to perform this function on behalf of a client.
Develops new, and enhances existing, client relationships whenever possible
Presents pharmacovigilance capabilities to clients as a participant of a proposal team, when appropriate
Supports Company’s visibility and position within the contract research organization environment through publications and presentations at national or international meetings
MD or DO 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