Remote Medical Safety Director Job at IQVIA
Looking to lead global drug safety and pharmacovigilance projects with a world-renowned CRO? IQVIA is hiring an Associate Medical Safety Director for a home-based, Pan India role. This Remote Medical Safety Director Job in India is ideal for experienced MBBS or MD professionals with strong expertise in Signal Management, Aggregate Reporting, and Pharmacovigilance. If you have over seven years of PV experience and are passionate about ensuring patient safety throughout the drug development lifecycle, this role at IQVIA Careers offers an exciting opportunity to work on global clinical trials and post-marketing safety programs.
About the Company:
IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services for the life sciences industry. Operating in more than 100 countries, IQVIA helps pharmaceutical, biotechnology, medical device, and healthcare organizations accelerate innovation, improve patient outcomes, and bring life-changing therapies to market. Through its expertise in clinical development, real-world evidence, and pharmacovigilance, IQVIA plays a critical role in advancing global healthcare.
Job Description:
- Job Title: Associate Medical Safety Director
- Job Location: Pan India
- Work Mode: Home-Based
- Job Type: Full-Time
- Department: Medical Safety / Pharmacovigilance
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 meeting
- 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 Report
- 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 Meeting
- 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 project.
- Provide medical escalation support for EU Qualified Persons for Pharmacovigilance projects
- 24-hour medical support as required on assigned project
- Maintain awareness of medical-safety-regulatory industry developments
Educational Requirements for the Remote Medical Safety Director Job:
- MBBS from an accredited and internationally recognized medical school.
- MD is also eligible and preferred.
- Valid medical registration or medical license (preferred).
- Minimum 7+ years of Pharmacovigilance experience.
- Minimum 4+ years of experience in Signal Management and Aggregate Reporting.
Qualifications Required for the Remote Medical Safety Director Job:
- 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 Prerf.
