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 Companys 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.Managerial Responsibilities
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
Salary: Not Disclosed by Recruiter
Role Category:Medical Professional
Employment Type:Permanent Job, Full Time
Desired Candidate Profile
Medical Directors are most successful at Covance with
MD or MBBS 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 board-certified
At least 8+ years of experience in pharmacovigilance & drug safety working either for a pharmaceutical company, health authority or a contract research organization
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.
UG:MBBS - Medicine
PG:Medical-MS/MD - Any Specialization, Any Postgraduate - Any Specialization
Doctorate:Doctorate Not Required
Covance India Pharmaceutical services pvt ltd.
Contact Company:Covance India Pharmaceutical services pvt ltd.