Director of Pharmacovigilance & Safety
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:
-Conducts medical case review and data summarization of adverse events.
-Provides advice related to GCP and regulatory issues to clients, study sites and internal departments.
-Determines methods and procedures for new assignments.
- 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
- 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
ABOUT KAI RESEARCH:
- KAI Research's dynamic work environment emphasizes integrity, personal commitment, and teamwork. In addition to the meaningful and challenging work, KAI offers an outstanding benefits program that includes paid time off, tuition reimbursement, 401k (5% employer contribution), a flexible work environment, and much more. We invite you to explore exciting and rewarding career opportunities with us.
- KAI is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to, among other things, race, color, religion, sex, sexual orientation, gender identity, national origin, age, status as a protected veteran, or disability.
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