In your role as Medical Director you will be,
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 drug safety activities for clients.
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
Assumes responsibility for safety monitoring on assigned projects
Interacts with inter-departmental and external consultants as appropriate
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.
Business Development Activities
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
Develops new, and enhances existing, client relationships whenever possible.
Ensures adequate coverage of all project related duties
Responsible for communicating status of projects and other activities to the Senior Medical Director (Lead) and others as appropriate.
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
Involved in identification, interviewing and selection of candidates for Associate Medical Director and other staff positions such as DSPMs, Managers and Director of Operations as applicable.
THANKS & REGARDS
DIRAA HR SERVICES