Senior Medical Safety Advisor
Job ID: R1523538
Location: Bengaluru, India
Work Model: Home-Based / Remote
Employment Type: Full-Time
Additional Locations: Available
Industry: Pharmacovigilance | Medical Safety | Drug Safety | Clinical Research
Job Overview
The Senior Medical Safety Advisor provides senior-level medical and scientific expertise across the pharmacovigilance lifecycle, supporting both clinical trial and post-marketing safety activities. This role is responsible for the medical evaluation of safety data from multiple sources, interpretation of serious adverse event reports, and oversight of product safety profiles across therapeutic areas.
In addition to hands-on medical safety review, this position serves as a technical leader, contributing to matrix management, safety surveillance strategy, signal detection, and preparation of aggregate safety reports in collaboration with post-marketing safety and surveillance teams.
Key Responsibilities
Perform detailed medical review and assessment of Adverse Events (AEs) and post-marketing Adverse Drug Reactions (ADRs), including narratives, coding, seriousness, causality, expectedness, and medical summaries.
Author, review, and medically approve Analyses of Similar Events (AOSE) for expedited regulatory submissions in compliance with global requirements.
Conduct medical and coding review of AEs, SAEs, SADRs, medical history, and concomitant medications to ensure clinical accuracy and regulatory compliance.
Act as a medical subject matter expert and internal consultant to pharmacovigilance case processing and safety operations teams.
Perform medical safety review of clinical protocols, Investigator’s Brochures, and Case Report Forms (CRFs) to ensure appropriate safety data capture.
Lead and contribute to aggregate safety reviews, including DSURs, RMPs, PBRERs, literature surveillance, observational studies, and ad hoc regulatory reports.
Ensure safety deliverables meet productivity, quality, compliance, and contractual timelines, and lead initiatives to improve delivery performance.
Provide therapeutic area and pharmacovigilance guidance while mentoring and supporting junior safety team members.
Maintain and update watch lists, expectedness listings, labeling references, and Reference Safety Information (RSI) for assigned products.
Lead and support training programs, product transitions, audit readiness activities, and knowledge-sharing initiatives.
Review and approve Project Safety Plans and Medical Monitoring Plans as per contracted medical safety scope.
Represent medical safety and clinical data review findings during client, sponsor, and internal governance meetings.
Serve as Lead Safety Physician, back-up, or senior medical safety support on assigned programs.
Provide medical escalation support for medical information activities and EU QPPV-related projects.
Deliver on-call medical safety support, including 24-hour coverage when required.
Participate in signal detection and safety surveillance activities, including strategy discussions and safety governance forums.
Maintain current knowledge of global pharmacovigilance regulations and industry developments.
Required Qualifications
Medical degree (MBBS/MD or equivalent) from an accredited and internationally recognized medical institution.
Minimum 5 years of total experience, including:
At least 3 years of clinical practice or residency training, and
2 or more years of experience in the pharmaceutical, CRO, or life sciences industry in pharmacovigilance or medical safety roles.
Strong knowledge of clinical medicine and therapeutic area concepts.
In-depth understanding of ICH-GCP, global regulatory requirements, and pharmacovigilance guidelines.
Proven expertise in ICSR processing, aggregate safety reports, and safety surveillance activities.
Familiarity with safety databases and pharmacovigilance systems.
Strong written and verbal communication skills, including medical writing and regulatory documentation.
Proficiency in Microsoft Word, Excel, and PowerPoint.
Ability to work effectively in cross-functional, matrixed, and global team environments.
Preferred Qualification:
Valid medical license or registration in the country of residence or employment.
Work Environment
Fully home-based / remote role with flexibility across global time zones.
May require extended availability for safety escalations and regulatory timelines.
About the Organization
IQVIA is a global leader in clinical research services, healthcare analytics, and commercial insights for the life sciences industry. By integrating data, technology, and medical expertise, IQVIA accelerates the development and delivery of innovative therapies that improve patient outcomes worldwide.
Equal Opportunity & Integrity Statement
The organization is committed to ethical hiring practices and maintaining integrity throughout the recruitment process. All application information must be accurate and complete. Any misrepresentation may result in disqualification or termination in accordance with applicable laws.
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