Senior Medical Safety Advisor
Bengaluru, India (Hybrid)
Also available in additional locations
Full-time
R1492686
This role involves providing expert medical evaluation of safety data from multiple sources across the pharmacovigilance process. The Senior Medical Safety Advisor determines the clinical and scientific relevance of serious adverse events (SAEs) and contributes as a senior technical leader. The position also includes responsibility for product safety surveillance, signal detection, and the preparation of aggregate safety reports in collaboration with post-marketing safety and surveillance teams.
Perform medical review of:
Clinical trial-related AEs and post-marketing ADRs
Narrative content, queries, expectedness, seriousness, causality, and coding (e.g., MedDRA)
Compose and review Analyses of Similar Events (AOSE) for expedited reporting.
Conduct coding review for AEs, SAEs, SADRs, past medical history, and concomitant medication listings.
Perform safety-focused reviews of:
Clinical protocols
Investigator brochures
Case report forms (CRFs)
Project safety plans and medical monitoring plans
Conduct aggregate safety data review from sources like:
Clinical studies
Post-marketing data
Literature reviews
Observational studies
Contribute to or author regulatory reports such as:
DSURs
RMPs
PBRERs
Ad hoc regulatory safety reports
Ensure timely, high-quality service delivery in compliance with regulatory/contractual expectations.
Provide leadership for safety case processing teams and single case assessments.
Maintain, update, and oversee:
Watch lists
Reference Safety Information (RSI)
Labeling expectations
Lead or contribute to:
Team training
Audit preparation
Knowledge sharing
Product transitions
Attend and present findings at:
Project meetings
Safety team meetings
Client discussions
Serve as Lead Safety Physician, support resource, or backup for assigned projects.
Provide escalation support for:
Medical information projects
EU QPPV (Qualified Person for Pharmacovigilance) engagements
Deliver 24/7 medical support for assigned projects, as needed.
Participate in signal detection strategy meetings and other safety evaluation initiatives.
Stay current with evolving safety and regulatory industry trends.
| Requirement | Details |
|---|---|
| Education | Medical degree from an accredited and internationally recognized institution (Required) |
| Clinical Experience | Minimum 3 years of clinical practice post-degree (Residency training may count) |
| Pharmaceutical Experience | At least 2 years in a pharma/biotech setting (Preferred) |
| Medical Knowledge | Strong understanding of general medicine and therapeutic areas |
| Regulatory Knowledge | In-depth knowledge of GCP, ICH guidelines, and pharmacovigilance regulations |
| PV Knowledge | Proficiency in ICSR handling and aggregate safety reporting |
| Tools & Systems | Skilled in multiple safety databases; proficient in MS Word, Excel, PowerPoint |
| Communication Skills | Excellent verbal and written communication |
| Teamwork | Ability to work effectively with cross-functional teams, clients, and regulatory agencies |
| Licensure | Valid medical license (Preferred but not mandatory) |
IQVIA is a global leader in clinical research, real-world evidence, and health data analytics. IQVIA connects data, technology, and expertise to drive healthcare innovation, enabling the development of better therapies and improved patient outcomes.
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Berlin |Germany :
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