KAI Research, an Altarum company is recruiting for a Director of Pharmacovigilance & Safety. “Are you ready for a challenge in overseeing and managing our infrastructure to support the medical component involving the activities of drug safety associates?” We seek your expertise to monitor and evaluate the safety of investigational and marketed drugs for clients from the pharmaceutical industry and other research institutions. Other responsibilities include:
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-Provides advice related to GCP and regulatory issues to clients, study sites and internal departments.
-Determines methods and procedures for new assignments.
Responsibilities:
Oversees day-to-day activities of drug safety staff; works closely with team members to ensure timely and accurate reporting of critical information
Develops Standard Operating Procedures (SOPs) for drug safety surveillance, adverse event and drug coding
Provides consultation to Research Operations and IT staff, clinical study site personnel and communicates regularly with clients
Develops signal detection, literature review, trend analysis, and risk evaluation and mitigation strategies
Investigates, evaluates and conducts medical review of adverse event reports associated with investigational and marketed drugs
Performs and reviews coding of adverse drug experiences and drugs for clinical trials and post marketing safety surveillance
Prepares and reviews expedited safety reports for submission to the FDA
Prepares and reviews periodic adverse drug experience reports for submission to the FDA
Gathers complete serious adverse event information and other documents for Data Safety Monitoring Boards (DSMBs)
Participates in SAE reconciliation between the safety and clinical database
Reviews post-marketing adverse events (AEs) and clinical trial SAEs with drug safety associates
Assures compliance with SOPs and FDA regulations for the reporting of adverse events to regulatory agencies
Reviews study protocols, final study reports and other safety related documents
Acts as liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements
Develops and prepares reports for company management as well as external regulatory agencies
Assists in the selection and hiring of drug safety personnel. Evaluates employee performance
Participates in clinical team meetings and other safety related meetings
Qualifications:
Medical Degree required along with 7-10 years’ experience in premarketing and post marketing drug safety
Supervisory experience required
Experience in medical care and clinical operations
Knowledge of FDA regulations and ICH guidance related to drug safety
Ability to build and maintain good working relationships with clients, patients and healthcare professionals
Excellent oral and written communication skills
Proficiency with Microsoft Officeand database software
Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members
Analytical thinker with excellent problem solving skills and the ability to adapt to changing priorities and deadlines
Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects
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