Associate Medical Safety Director (R1090322) - Durham, NC - IQVIA™

Date de publication 12/2/2019

Résumé de l'offre

  • Type d'employé
    CDI / CNE
  • Expérience
    Not Specified
  • Date de publication
    12/2/2019
  • Job ID:
    R1090322

Description de l'offre

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.

PURPOSE

Provide medical expertise on pharmacovigilance services to all IQVIA divisions as requested. The Associate 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.

RESPONSIBILITIES

 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, US Periodic Benefit Risk Evaluation Reports, US Periodic Safety Update Reports, US 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

 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 US Qualified Persons for Pharmacovigilance projects

 24 hour medical support as required on assigned projects

 Maintain awareness of medical-safety-regulatory industry developments

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

 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

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

 A medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education and 5 years’ experience practicing clinical medicine after award of medical degree; or equivalent combination of education, training and experience; Graduate medical training can qualify for clinical practice experience; Three years of clinical practice experience with two additional years as a pharmaceutical physician in any role can also suffice.

 A valid medical license, or equivalent, from the country or region in which he/she resides and works – would be a plus.

PHYSICAL REQUIREMENTS

 Extensive use of telephone, email, and face-to-face communication requiring accurate perception and elocution of spoken and written English

 The ability to travel based on client or company needs, <5% of time

Join Us

Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.

Forge a career with greater purpose, make an impact, and never stop learning.

IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled

IQVIA, Inc. provides reasonable accommodations for applicants with disabilities.  Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.



Job ID: R1090322