Senior Physician – Patient Safety (Pharmacovigilance)
Location: India (Remote)
Job Type: Full-Time
Department: Medical Sciences / Drug Safety
Industry: Clinical Research Organization (CRO) / Pharmaceutical / Biotechnology
Job ID: R0000038057
Job Overview
A leading global Clinical Research Organization (CRO) is seeking an experienced Senior Physician – Patient Safety to lead medical safety review, pharmacovigilance, and risk management activities across assigned products and therapeutic areas.
This is a remote, India-based opportunity for medically qualified professionals with strong expertise in drug safety, medical monitoring, signal detection, and regulatory compliance. The role requires in-depth clinical evaluation, leadership in safety governance, and mentorship of junior physicians while supporting global pharmacovigilance operations.
The Senior Physician will serve as a Subject Matter Expert (SME), ensuring patient safety, regulatory compliance, and high-quality medical oversight throughout the drug development lifecycle.
Key Responsibilities
Pharmacovigilance & Case Medical Review
Perform comprehensive medical review of individual case safety reports (ICSRs), including clinical trial, post-marketing, and literature cases
Assess seriousness, expectedness, causality, and listedness of adverse events
Author Pharmacovigilance/Marketing Authorization Holder (MAH) comments
Ensure accurate MedDRA coding and narrative medical coherence
Provide medical guidance to case processing teams
Review complex and combination product (drug-device) safety cases
Aggregate Safety Reporting & Regulatory Documents
Author and review key safety documents including:
PBRERs / PSURs
DSURs
Signal Evaluation Reports (SERs)
Health Authority response documents
Clinical Overviews and Addenda
Health Hazard Evaluation (HHE) reports
Contribute to regulatory submissions (IND, NDA, MAA, variations, renewals)
Review safety sections of Company Core Data Sheet (CCDS) and labeling documents
Signal Detection & Risk Management
Conduct signal detection, validation, and evaluation activities
Perform medical assessment of safety alerts from data mining
Author and review SERs and signal validation documents
Manage signal tracking systems and safety management tools
Participate in Safety Management Team (SMT) meetings
Support Risk Management Plan (RMP) preparation and maintenance
Medical Monitoring & Clinical Oversight
Provide medical monitoring support for clinical studies
Review adverse events, laboratory data, and safety line listings
Sign off on medically relevant technical documents
Support Data Monitoring Committees (DMCs) and Clinical Endpoint Committees (CECs)
Provide safety input into clinical protocols, study reports, and Investigator’s Brochures
Literature Review & Safety Intelligence
Conduct literature review for product safety assessment
Summarize literature findings for aggregate reporting and signal management
Perform medical review of Clinical Study Report (CSR) narratives
Leadership & Cross-Functional Collaboration
Serve as Therapeutic Area Subject Matter Expert (SME)
Mentor and train junior Patient Safety Physicians
Participate in client meetings, audits, inspections, and bid defense meetings
Collaborate with regulatory, clinical, medical writing, and project teams
Contribute to process improvements and KPI performance
Required Education
MBBS / MD or medically qualified degree from a recognized medical school
Completion of clinical training (internship/residency) required
Required Experience
Minimum 5–8+ years of relevant experience in:
Pharmacovigilance / Drug Safety
Medical Monitoring
Clinical Practice (general or specialist)
Experience in aggregate safety reporting and regulatory documentation
Strong understanding of global drug safety regulations (ICH-GCP, ICH-GVP, and applicable international guidelines)
Experience mentoring junior physicians preferred
Technical Knowledge & Skills
Advanced knowledge of pharmacovigilance processes and global reporting obligations
Strong expertise in signal detection and safety evaluation methodologies
Ability to interpret complex clinical and safety data
Experience with MedDRA coding review
Familiarity with global regulatory authority requirements
Proficiency in Microsoft Office and web-based safety systems
Core Competencies
Strong clinical judgment and analytical thinking
Excellent written and verbal communication skills
Ability to manage multiple complex safety projects
Client-focused and solution-oriented approach
High attention to detail and regulatory compliance mindset
Ability to work effectively in a global matrix environment
Leadership and mentoring capability
Why Apply
Work remotely in a global pharmacovigilance leadership role
Contribute to patient safety across international drug development programs
Engage with regulatory authorities and global health stakeholders
Mentor and develop future medical safety leaders
Be part of high-impact drug safety and risk management initiatives
Apply Now
Advance your career in Pharmacovigilance, Medical Monitoring, and Global Drug Safety by joining a world-class medical sciences team dedicated to protecting patient safety and supporting regulatory excellence worldwide.
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