Job Overview :
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.
This is a remote-based position with up to 10% travel.
Essential Job Duties :
Medical review of serious adverse events derived from clinical trials, in support of drug safety activities for clients
Preparation and medical review of Aggregate Reports required by global regulatory agencies for review of safety information for assigned products.
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.
Provide medical / safety expertise to project teams, including communicating information regarding drug safety regulations and any changes that have occurred
Participate in training opportunities to advance knowledge of pharmacovigilance as it relates to drug / product development and drug / product marketing utilizing good clinical practice guidelines
Provide pharmacovigilance support to project physicians, as appropriate
Participate in project risk assessment activities
Review 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
Assist in the preparation of pharmacovigilance materials for investigator meetings
Provides mentoring to and responsible for supervision of Associate Medical Directors and Senior Managers, and mentoring to and indirect supervision of Senior Drug Safety Associates, and Drug Safety Associates
Ensure adequate coverage of all project related duties
Present pharmacovigilance capabilities to clients as a participant of a proposal team, when appropriate
Develop new and enhances existing client relationships whenever possible
Education / Qualifications :
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 is highly preferred.
Substantial knowledge of pharmacovigilance and the global regulations governing drug / biologics / device safety activities both during clinical development and during the post-marketing phase of lifecycle management.
At least 3 years of experience in pharmacovigilance & risk management working either for a pharmaceutical company, health authority or a contract research organization