Associate Medical Safety Director
📍 Location: Bengaluru, India (Home-based)
💼 Job ID: R1500619
🌍 Additional Location: Bengaluru, India
🕒 Type: Full-time
About the Role
IQVIA is seeking an Associate Medical Safety Director to provide medical expertise in pharmacovigilance and ensure clinical safety oversight across global studies and standalone safety projects.
You’ll play a key role in evaluating, managing, and communicating drug safety data, collaborating closely with internal teams and sponsors under appropriate senior oversight.
Key Responsibilities
1. Adverse Event and Safety Review
Perform medical review and clarification of trial-related Adverse Events (AEs) and post-marketing Adverse Drug Reactions (ADRs).
Assess narrative content, queries, coding, expectedness, seriousness, causality, and company summaries.
Compose, edit, and review Analyses of Similar Events (AOSE) for expedited cases per regulatory standards.
2. Clinical & Safety Oversight
Act as an internal consultant for pharmacovigilance case processing teams.
Conduct aggregate reviews of clinical and safety data to maintain oversight of a product’s safety profile.
Review coding of AEs, medical history, and concomitant medications for accuracy and medical relevance.
Represent medical safety and clinical review findings in client and cross-functional meetings.
3. Regulatory Document Review
Provide medical input and review for:
IND Annual Reports
Periodic Benefit-Risk Evaluation Reports (PBRER)
Periodic Safety Update Reports (PSUR)
Development Safety Update Reports (DSUR)
US Periodic Reports
Contribute to Risk Management Plans (RMP), Risk Evaluation and Mitigation Strategies (REMS), and Drug Safety Reports.
Review and sign off Project Safety Plans and Medical Monitoring Plans as per project scope.
4. Strategic & Operational Contributions
Provide medical oversight for labeling, including development, review, and updates.
Participate in Data Safety Monitoring Board (DSMB) and Safety Monitoring Committee meetings.
Support the Integrated Safety Summary (ISS) and Common Technical Document (CTD) submissions.
Conduct medical safety reviews of protocols, Investigator’s Brochures (IBs), and Case Report Forms (CRFs) for safety data integrity.
Act as Global Safety Physician, Assistant, or Back-up on assigned projects.
Ensure timely delivery of all medical safety commitments and regulatory submissions.
5. Medical Escalation & Support
Provide 24-hour medical support for assigned projects.
Offer escalation support for Medical Information and Qualified Person for Pharmacovigilance (QPPV) projects.
Maintain up-to-date knowledge of medical, safety, and regulatory developments within the industry.
Qualifications
Education
Required: Medical Degree (M.D. or equivalent) from an accredited and internationally recognized institution.
Preferred: Valid medical license (or equivalent) in the country of residence.
Experience
Minimum: 3 years of clinical practice (e.g., graduate medical training) plus 2 years in the pharmaceutical or allied industry; or an equivalent combination of education and experience.
Skills & Knowledge
Strong understanding of pharmacovigilance regulations, Good Clinical Practice (GCP), and drug safety guidelines.
Knowledge of clinical trial processes and global regulatory requirements.
Ability to prioritize, meet deadlines, and handle multiple concurrent projects.
Excellent analytical, consultative, and decision-making skills.
Strong communication and collaboration abilities with cross-functional and client teams.
High degree of initiative, flexibility, and professional judgment.
About IQVIA
IQVIA is a global leader in clinical research, commercial insights, and healthcare analytics, empowering life sciences companies to accelerate innovation and improve patient outcomes.
We connect data, technology, and expertise to transform the future of healthcare.
🌐 Learn more: https://jobs.iqvia.com
Apply Now
If you’re a medical professional with strong pharmacovigilance experience and a drive for patient safety and data excellence —
👉 Apply now to join IQVIA as an Associate Medical Safety Director.
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