Senior Medical Safety Advisor – Pharmacovigilance | Bengaluru, India | Home-Based
Location: Bengaluru, Karnataka, India
Employment Type: Full-Time, Home-Based
Experience Required: Minimum 3 years clinical practice + 2 years pharmaceutical/pharmacovigilance experience
Industry: Healthcare / Pharmacovigilance / Clinical Safety
About IQVIA
IQVIA is a global leader in clinical research services, healthcare intelligence, and commercial insights for the life sciences and healthcare industries. We leverage advanced analytics, technology, and deep domain expertise to accelerate the development and commercialization of innovative medical treatments, improving patient outcomes and population health worldwide.
At IQVIA, we foster an inclusive and collaborative environment where talented professionals drive meaningful impact on global healthcare.
Role Overview
As a Senior Medical Safety Advisor, you will provide advanced medical expertise in the evaluation and interpretation of safety data from multiple sources within the pharmacovigilance process. You will assess the medical and scientific relevance of serious adverse event (SAE) reports, maintain oversight of product safety profiles, and serve as a senior technical leader within cross-functional safety teams.
This role requires a strong medical background, proficiency in pharmacovigilance regulations, and experience in signal detection, aggregate reporting, and clinical safety assessments.
Key Responsibilities
Perform medical review and clarification of trial-related Adverse Events (AEs) and post-marketing Adverse Drug Reactions (ADRs), including narratives, coding, seriousness, expectedness, causality, and company summaries.
Prepare, edit, and medically review Analyses of Similar Events (AOSE) and expedited cases per global regulatory requirements.
Conduct coding review for AEs, SAEs, SADRs, concomitant medications, and past medical history to ensure clinical accuracy and data integrity.
Serve as an internal medical consultant for pharmacovigilance case processing teams.
Review protocols, Investigators’ Brochures, and Case Report Forms (CRFs) for appropriate safety content and data capture.
Lead aggregate safety reviews, including clinical data, post-marketing surveillance, literature reviews, and observational studies, contributing to DSURs, RMPs, PBRERs, and ad hoc regulatory reports.
Provide guidance on therapeutic area-specific pharmacovigilance issues and lead single case assessments.
Maintain product safety oversight tools, including watch lists, expectedness tables, and labeling/RSI updates.
Lead and participate in training, product transitions, audit preparation, and knowledge-sharing initiatives.
Review and approve Project Safety Plans and Medical Monitoring Plans in alignment with contract agreements.
Represent medical safety findings in project and client meetings, serving as Lead Safety Physician or support backup as required.
Provide medical escalation support and 24-hour safety coverage for assigned projects.
Stay updated on medical, safety, and regulatory developments globally.
Support signal detection efforts, safety strategy meetings, and risk mitigation initiatives.
Required Qualifications & Experience
Medical Degree: Accredited, internationally recognized medical degree relevant to general medical education.
Clinical Experience: Minimum 3 years practicing clinical medicine post-medical degree. Graduate and/or residency training qualifies.
Pharmaceutical/Pharmacovigilance Experience: Minimum 2 years in pharmacovigilance, clinical research, or related pharmaceutical roles.
Strong knowledge of Medicine and therapeutic areas.
In-depth understanding of global, regional, and local clinical research regulatory requirements, including GCP and ICH guidelines.
Expertise in pharmacovigilance processes, including ICSR handling and aggregate reporting.
Proficiency with multiple safety databases and Microsoft Office applications.
Strong verbal and written communication skills.
Ability to build and maintain effective relationships with managers, colleagues, clients, investigators, and regulatory authorities.
Valid medical license or equivalent, preferred in the country/region of residence.
Why Join IQVIA
Work with a global leader in clinical research and healthcare intelligence.
Participate in impactful projects that improve patient safety and healthcare outcomes.
Collaborate with multidisciplinary teams in a flexible, home-based environment.
Access to professional development, training programs, and knowledge-sharing initiatives.
Competitive compensation and benefits, including health coverage, retirement plans, and employee assistance programs.
IQVIA is committed to equal opportunity employment. All qualified candidates will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. Reasonable accommodations are provided for qualified individuals with disabilities or for religious observances.
Apply now to join IQVIA and contribute to advancing global pharmacovigilance and patient safety initiatives.
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