Senior Medical Safety Advisor (Pharmacovigilance)
Location: Bengaluru, India
Work Mode: Home-Based / Remote
Employment Type: Full-Time
Reference ID: R1471135
About the Organization
IQVIA is a global leader in clinical research services, healthcare intelligence, and commercial insights, supporting the life sciences industry in accelerating the development and safe use of innovative therapies. With a strong global footprint, IQVIA partners with pharmaceutical, biotech, and healthcare organizations to improve patient outcomes and population health worldwide.
Role Overview
The Senior Medical Safety Advisor plays a critical leadership role within the Pharmacovigilance and Medical Safety function. This position provides expert medical judgment in the evaluation, interpretation, and surveillance of safety data across clinical development and post-marketing phases. The role also contributes as a senior technical leader, supporting matrix teams, regulatory deliverables, and safety strategy for assigned products and therapeutic areas.
This opportunity is well-suited for physicians with strong pharmacovigilance expertise seeking a remote, high-impact global role in drug safety.
Key Responsibilities
Conduct comprehensive medical review of clinical trial and post-marketing safety data, including AEs, SAEs, ADRs, coding, causality, seriousness, expectedness, and narrative assessments.
Author, edit, and medically review Analyses of Similar Events (AOSE) for expedited safety cases in compliance with global regulatory requirements.
Perform medical review of coding for adverse events, medical history, concomitant medications, and clinical data listings.
Serve as a medical safety consultant to pharmacovigilance case processing and surveillance teams.
Review protocols, Investigator’s Brochures, and CRFs to ensure appropriate safety content and data capture.
Lead and contribute to aggregate safety reporting, including DSURs, PBRERs, RMPs, and ad hoc regulatory submissions.
Ensure compliance with regulatory timelines, quality standards, and contractual obligations for assigned products.
Provide therapeutic area expertise and mentorship to safety team members involved in single-case assessments.
Maintain and update product safety documentation, including watch lists, RSI lists, labeling, and expectedness criteria.
Lead training initiatives, product transitions, audit readiness activities, and knowledge-sharing programs.
Review and approve Project Safety Plans and Medical Monitoring Plans as per contractual scope.
Represent medical safety findings in internal, cross-functional, and client-facing meetings.
Act as Lead Safety Physician or backup support across assigned projects as required.
Support signal detection, risk evaluation, and ongoing safety surveillance activities.
Stay current with evolving global pharmacovigilance regulations and medical safety standards.
Provide medical escalation support and 24-hour on-call coverage for assigned projects when required.
Required Qualifications & Experience
Medical Degree: MD or equivalent from an accredited and internationally recognized medical school.
Clinical Experience:
Minimum 3 years of post-graduate clinical practice, including residency or supervised clinical training.
Pharmacovigilance Experience:
2+ years of experience in pharmaceutical, CRO, or drug safety roles preferred.
Regulatory & Safety Knowledge:
Strong understanding of GCP, ICH guidelines, and global clinical research regulations.
Hands-on experience with ICSR processing and aggregate safety reports.
Technical Skills:
Proficiency in safety databases and medical coding systems.
Strong MS Word, Excel, and PowerPoint skills.
Professional Competencies:
Excellent written and verbal communication skills.
Ability to collaborate effectively with global cross-functional teams, clients, and regulatory stakeholders.
Demonstrated leadership, decision-making, and mentoring capabilities.
Licensure:
Valid medical license in country of residence is preferred.
Why Join IQVIA
Work remotely on global pharmacovigilance programs with high scientific and regulatory impact.
Collaborate with leading experts across drug safety, clinical research, and regulatory science.
Access continuous professional development, leadership opportunities, and global career pathways.
Contribute directly to improving patient safety and advancing innovative therapies worldwide.
Equal Opportunity Statement
IQVIA is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, gender, sexual orientation, age, disability, veteran status, or any other protected characteristic.
SEO Keywords Optimized
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