Senior Medical Director, Pharmacovigilance at The Judge Group Inc. in Miami, Florida

Job Description:

Location: REMOTE

Salary: $260,000.00 USD Annually - $280,000.00 USD Annually

Description: Our client is currently seeking a Senior Medical Director, Pharmacovigilance
The Senior Medical Director, PV will serve as a thought leader, with a high level of experience as a medical safety professional with a strong ability and broad knowledge of global drug safety, medical monitoring, and post marketing safety surveillance. This role will lead the drug safety and pharmacovigilance operations to ensure the consistency and accuracy of adverse event reporting in clinical studies including, but not be limited to, initial safety review of adverse events, medical review of clinical data, interaction with clinical research sites, drug safety vendors, review of source documents, preparation of documents for submission to regulatory authorities, medical monitoring support to clinical trial sites for questions related to clinical trial, and for emergency unblinding.



This job will have the following responsibilities:



• Provide leadership to the pharmacovigilance function and multi-disciplinary study teams.


• Manage and lead the PV group, manage resources, and budget pertinent to the PV activities.


• Serve as a medical monitor/advisor of ongoing clinical trials.


• Ensure compliance with all applicable laws and regulations and as appropriate, local, and foreign regulatory requirements, for the processing and reporting of adverse events in coordination with regulatory affairs.


• Responsible for the overall clinical risk management and safety surveillance of all future investigational products.


• Provide medical review and advice of post marketing safety data.


• Prepare/oversee medical monitoring plans and present the study protocol's safety in the IM meetings and site initiation activities.


• Act as 24/7 available medical contact person for questions related to clinical trial and for emergency unblinding.


• Medical review of coding, ensure accuracy of MedDRA coding of adverse events' terms, medical history, and WHO Drug coding of concomitant medications.


• Medical review of eCRF related to clinical and safety data.


• Medical review of individual case safety report (ICSR): adverse events (AEs), serious adverse events (SAEs), adverse events of special interest (AESIs), adverse drug reactions (ADR), causality assessment, signal detection, case narrative, aggregate reports, medical review of listings of safety data.


• Write/review the relevant safety sections of the NDA and different types of regulatory meeting packages.


• Provide medical input and review of annual reports, PADER, PSUR, DSUR, other benefit risk assessment reports, updates of package insert/label, summary of product characteristics, and investigator's brochure.


• Prepare and review the answers to questions from Health Authorities, medical input in Risk Management Plan (RMP).


• Participate in DSMB preparation and activities.
Qualifications & Requirements:



• MD or DO, with relevant post-graduate clinical training.


• Minimum of 8 years of relevant work experience.


• Experience in NDA and IND submissions.


• Knowledge of medical and therapeutic terminology.


• Deep understanding of the drug development process (preferred in CNS therapeutic areas).


• Strong knowledge of regulatory requirements (GCP, ICH guidelines) and worldwide safety regulations.


• Experience in managing PV budgets and financial risk in clinical research.


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Contact: arawat@judge.com


This job and many more are available through The Judge Group. Find us on the web at www.judge.com