Sr. Medical Safety Advisor – Pharmacovigilance
Bengaluru, India | Full-Time | Home-Based | Job ID: R1524203
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Join a global healthcare organization dedicated to advancing patient safety, clinical excellence, and regulatory compliance across the pharmaceutical and life sciences industry. This opportunity is designed for experienced medical professionals seeking leadership exposure in pharmacovigilance and drug safety surveillance.
Job Overview
The Sr. Medical Safety Advisor provides medical and scientific expertise in evaluating safety data from multiple sources as part of global pharmacovigilance activities. The role involves assessing the medical significance of serious adverse events and determining their relevance within a product’s safety profile and related therapeutic areas.
As a senior technical leader, the position contributes to matrix management initiatives, safety issue evaluation, and preparation of aggregate safety reports. The role collaborates closely with Post-Marketing Safety Experts and Safety Surveillance teams while managing surveillance activities for assigned products.
Key Responsibilities
Conduct medical review and assessment of clinical trial-related Adverse Events (AEs) and post-marketing Adverse Drug Reactions (ADRs), including narrative review, coding, expectedness, seriousness, causality evaluation, and medical summaries.
Prepare, edit, and medically review Analyses of Similar Events (AOSE) for expedited safety cases in accordance with regulatory requirements.
Review coding and clinical data related to AEs, Serious Adverse Events (SAEs), Serious Adverse Drug Reactions (SADRs), medical history, and concomitant medications to ensure clinical accuracy.
Act as an internal medical consultant for pharmacovigilance case processing teams.
Review safety components of clinical study protocols, Investigative Brochures, and Case Report Forms to ensure appropriate safety data collection.
Perform aggregate safety evaluations using clinical data, post-marketing reports, scientific literature, and observational studies to maintain product safety oversight (DSUR, RMP, PBRER, and regulatory reports).
Ensure high-quality service delivery, compliance, and productivity within regulatory and contractual timelines.
Provide therapeutic area and pharmacovigilance guidance to safety teams during single case assessments.
Maintain and update safety watch lists, expectedness documentation, and labeling information for assigned products.
Lead training programs, audit preparation activities, product transitions, and knowledge-sharing initiatives.
Review and approve Project Safety Plans and Medical Monitoring Plans as per contractual requirements.
Participate in project and client meetings, presenting clinical safety findings and recommendations.
Serve as Lead Safety Physician or provide backup medical support for assigned projects.
Provide medical escalation support for pharmacovigilance and regulatory activities, including collaboration with EU Qualified Persons for Pharmacovigilance where applicable.
Provide 24-hour medical support for assigned projects when required.
Monitor global regulatory developments and industry trends related to medical safety.
Contribute to signal detection strategies and safety evaluation initiatives.
Required Qualifications and Experience
Medical degree from an accredited and internationally recognized medical institution.
Minimum 3 years of clinical practice experience after obtaining a medical degree (residency or postgraduate training may be considered).
Strong knowledge of clinical medicine and patient safety practices.
In-depth understanding of global clinical research regulations, including Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
Knowledge of pharmacovigilance processes, including Individual Case Safety Reports (ICSR) and aggregate safety reporting.
Familiarity with departmental standard operating procedures and safety database systems.
Proficiency in Microsoft Office tools, including Word, Excel, and PowerPoint.
Strong written and verbal communication skills.
Ability to collaborate effectively with internal teams, clients, regulatory authorities, and stakeholders.
Equivalent combination of education, clinical practice experience, or pharmaceutical industry experience may be considered.
Preferred Qualifications
Minimum 2 years of experience in the pharmaceutical or life sciences industry, including pharmacovigilance or clinical research roles.
Valid medical license or equivalent certification in the country of practice.
About the Organization
IQVIA is a global leader in clinical research services, healthcare intelligence, and commercial insights for the life sciences industry. The organization enables the development and commercialization of innovative medical treatments by delivering data-driven solutions that improve patient outcomes and public health worldwide.
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