Medical Safety Dir

Job Overview

Provide medical expertise on pharmacovigilance services to all divisions as requested. The Medical Safety Director participates in all aspects of Medical Safety’s involvement on assigned trials and stand alone safety projects with appropriate oversight from management or more senior medical safety directors. The Medical Safety Director also provides global project leadership on projects requiring multiple medical safety advisors and mentorship to junior medical safety staff.

Essential Functions

Perform medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs) including narrative content, queries, coding, expectedness, seriousness, causality and company summary

Compose, edit and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements

Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported

Provide aggregate reviews of safety information, including clinical data, to maintain oversight of a product’s safety profile

Provide coding review of AEs, Past medical history, Concomitant medications or other medical data listings to verify and medically vet clinical data

Represent safety and clinical data review findings during client meetings

Provide medical review and edits to IND Annual Reports, EU Periodic Benefit Risk Evaluation Reports, EU Periodic Safety Update Reports, EU Development Safety Update Reports, US Periodic Reports

Provide medical review and edits of Development Risk Management Plans, EU Risk Management Plans or US Risk Evaluation and Mitigation Strategies

Provide medical oversight for label development, review and change

Provide medical support and attendance at Data Safety Monitoring Board Meetings

Attends and contributes medical safety evaluation on Safety Monitoring Committees

Provide medical safety contributions to the Integrated Safety Summary or Common Technical Document

Provide medical review and edits to Drug Safety Reports or other benefit-risk assessments

Review and sign off on both the Project Safety Plan and the Medical Monitoring Plan per medical safety scope agreed in contract

Perform Medical Safety review of the protocol, Investigative Drug Brochure (IDB), and/or Case Report Forms (CRFs) for appropriate safety content and data capture.

Act as Global Safety Physician or Assistant or Back-up on projects as assigned

Serve as the Global Lead for a medical safety project requiring a team of medical safety advisors; being responsible for project specific training, operational delivery, project communication, and quality control

Attend project meetings, medical safety team meetings, and client meetings as requested

Ensure coverage for all medical safety deliverables within regulatory or contracted timelines

Provide medical escalation support for medical information projects

Provide medical escalation support for EU Qualified Persons for Pharmacovigilance projects

24hour medical support as required on assigned projects

Maintain awareness of medical-safety-regulatory industry developments

Participates in the review of Requests for Proposal, vetting, proposing and budgeting of medical safety services

Attends bid defenses and other client meetings to promote and sell medical safety services

Qualifications

Other A medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education Req

Three (3) years of clinical practice experience (e.g graduate medical training) with four (4) additional years in the pharmaceutical or associated industry in any role. Or equivalent combination of education, training and experience Req

Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research including knowledge of regulations and guidelines pertaining to safety and good clinical practice

Knowledge of clinical trials and pharmaceutical research process

Ability to establish and meet priorities, deadlines, and objectives.

Skills in providing consultation and advice on multiple assignments required, as well as initiative and flexibility.

Ability to establish and maintain effective working relationships with coworkers, managers and clients

A valid medical license, or equivalent, from the country or region in which he/she resides and works Pref

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.