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Assoc Medical Safety Dir

2-3 years
Not Disclosed
10 Oct. 16, 2025
Job Description
Job Type: Full Time Remote Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Position: Associate Medical Safety Director

📍 Location: Bengaluru, India (Home-based)
🏢 Company: IQVIA
🕒 Employment Type: Full-Time
💼 Job ID: R1500619


About IQVIA

IQVIA is a global leader in clinical research services, commercial insights, and healthcare intelligence for the life sciences industry.
We create intelligent connections to accelerate the development and commercialization of innovative medical treatments — improving patient outcomes and population health worldwide.
🔗 Learn more: https://jobs.iqvia.com


Job Overview

The Associate Medical Safety Director (AMSD) provides medical expertise in pharmacovigilance across assigned trials and standalone safety projects. The AMSD participates in all aspects of medical safety, including review, analysis, consultation, and oversight, with appropriate guidance from senior medical safety directors.


Key Responsibilities

Medical Review & Oversight

  • Review and clarify trial-related Adverse Events (AEs) and post-marketing Adverse Drug Reactions (ADRs), including narrative content, queries, coding, expectedness, seriousness, causality, and company summaries.

  • Compose, edit, and medically review Analyses of Similar Events (AOSE) for expedited cases.

  • Provide aggregate reviews of safety information, including clinical data, to monitor product safety profiles.

  • Review AEs, medical history, concomitant medications, and other clinical data listings to verify and medically vet clinical information.

Regulatory & Clinical Documentation

  • Review and edit IND Annual Reports, EU/US Periodic Reports, Development Safety Update Reports, and Risk Management Plans.

  • Provide medical oversight for label development, review, and updates.

  • Contribute to Integrated Safety Summaries, Common Technical Documents, and Drug Safety Reports.

  • Perform medical review of protocols, Investigative Drug Brochures (IDB), and Case Report Forms (CRFs) for safety content.

Project & Stakeholder Management

  • Serve as internal consultant for pharmacovigilance case processing teams.

  • Represent safety and clinical data findings during client meetings.

  • Provide medical support and attend Data Safety Monitoring Board (DSMB) meetings and Safety Monitoring Committees.

  • Act as Global Safety Physician or back-up on assigned projects.

  • Ensure coverage for all medical safety deliverables within regulatory or contractual timelines.

  • Provide medical escalation support for medical information projects and EU Qualified Persons for Pharmacovigilance.

  • Maintain awareness of medical safety regulatory developments.

  • Be available for 24-hour medical support on assigned projects as required.


Qualifications & Requirements

Education & Licensure

  • Medical degree from an accredited, internationally recognized medical school.

  • Valid medical license (or equivalent) in the country/region of practice preferred.

Experience

  • 3 years of clinical practice (e.g., graduate medical training).

  • 2 additional years in the pharmaceutical or associated industry, or equivalent combination of education, training, and experience.

Knowledge & Skills

  • Knowledge of federal and local regulations and guidelines for clinical research and safety.

  • Understanding of clinical trials and pharmaceutical research processes.

  • Ability to prioritize tasks, meet deadlines, and manage multiple assignments.

  • Strong consultative, advisory, and problem-solving skills.

  • Excellent interpersonal skills to maintain effective working relationships with coworkers, managers, and clients.


Why Join IQVIA?

  • 🌍 Work with a global leader in clinical research and healthcare intelligence.

  • 💡 Contribute to pharmacovigilance and patient safety on a global scale.

  • 🤝 Collaborate in a home-based, flexible, and supportive work environment.

  • 🌐 Opportunities to advance your career and expertise in medical safety.


📩 Apply Now: IQVIA Careers – Associate Medical Safety Director