Remote Medical Job at IQVIA: Associate Medical Safety Director Role
If you are a doctor looking for a medical job that offers flexibility and global exposure, this opportunity with IQVIA could be the perfect fit. This remote job for doctors allows medical professionals to work on pharmacovigilance and clinical safety projects while contributing to global healthcare innovation. With the rise of work-from-home medical jobs, roles like Associate Medical Safety Director are becoming highly sought-after in the pharmaceutical and clinical research industry.
Job Details:
- Job Position: Associate Medical Safety Director
- Location: Thane, India | Full Time | Home-based
- Job ID: R1532084
About IQVIA:
IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. The company creates intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.
Through advanced analytics, technology solutions, and deep therapeutic expertise, IQVIA supports pharmaceutical and biotechnology companies in delivering breakthrough treatments to patients globally. For doctors looking for remote jobs for doctors, work-from-home medical jobs, or IQVIA careers, the company offers a range of opportunities across pharmacovigilance, medical affairs, and clinical development.
Job Description:
The Associate Medical Safety Director provides medical expertise on pharmacovigilance services to divisions as requested. The role 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.
This medical job plays an important role in ensuring drug safety, reviewing clinical data, and supporting regulatory compliance within clinical research projects. It is particularly suited for physicians looking for work from home medical jobs or professionals interested in growing their careers through IQVIA jobs.
Qualifications:
- A medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education
- Three (3) years of clinical practice experience (e.g graduate medical training) with two (2) additional years in the pharmaceutical or associated industry in any role, or equivalent combination of education, training and experience
- 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
Key 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, 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.
- Attend and contribute 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 the 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 EU Qualified Persons for Pharmacovigilance projects.
- 24-hour medical support as required on assigned projects.
- Maintain awareness of medical-safety-regulatory industry developments.
