Safety Surveillance Adviser
Department: Global Patient Safety (GPS)
Function: Regulatory Affairs & Pharmacovigilance
Location: Bangalore, Karnataka, India
Employment Type: Full-Time
Industry: Pharmaceutical / Biotechnology / Drug Safety / Pharmacovigilance
Position Overview
The Safety Surveillance Adviser is responsible for continuous evaluation, monitoring, and communication of the safety profile of products throughout the drug development and post-marketing lifecycle. The role plays a critical part in ensuring patient safety by conducting proactive safety surveillance, signal management, aggregate safety reporting, risk management, and benefit-risk evaluation activities.
As a key member of the Global Patient Safety (GPS) team, the Safety Surveillance Adviser collaborates with cross-functional stakeholders across Clinical Development, Regulatory Affairs, Medical Affairs, Epidemiology, Biostatistics, and Global Safety functions to maintain product safety profiles and support regulatory compliance worldwide.
The position requires expertise in pharmacovigilance, signal detection, risk management, aggregate reporting, and regulatory safety requirements.
Key Responsibilities
Safety Surveillance & Benefit-Risk Assessment
Perform continuous and systematic surveillance of assigned products during:
Clinical Development (Pre-Approval)
Post-Marketing (Post-Approval)
Monitor and evaluate safety information from global sources including:
Clinical Trials
Spontaneous Reports
Scientific Literature
Regulatory Authorities
Post-Marketing Surveillance Programs
Assess emerging safety concerns and evaluate benefit-risk profiles throughout the product lifecycle.
Support establishment and maintenance of product safety profiles.
Signal Management & Safety Evaluation
Conduct signal detection, validation, assessment, prioritization, and communication activities.
Review safety data to identify potential safety signals and trends.
Perform medical assessment of adverse events and safety information.
Collaborate with internal stakeholders to investigate and evaluate safety concerns.
Support risk minimization and pharmacovigilance activities.
Product Safety Governance
Establish, coordinate, and chair cross-functional Product Safety Committees.
Present safety analyses, risk assessments, and surveillance findings to safety governance bodies.
Facilitate safety committee discussions and recommendations.
Ensure documentation of committee decisions and safety actions.
Labeling & Core Safety Information
Act as the owner of safety sections within:
Company Core Data Sheet (CCDS)
Core Safety Information Documents
Product Labeling Documentation
Maintain safety-related labeling for marketed products.
Participate as a Labeling Change Request (LCR) Reviewer.
Provide scientific and medical safety input during labeling updates and revisions.
Support implementation of global labeling strategies.
Aggregate Safety Reporting
Author and Review:
Development Safety Update Reports (DSURs)
Periodic Safety Update Reports (PSURs)
Periodic Benefit-Risk Evaluation Reports (PBRERs)
Serious Unexpected Suspected Adverse Reaction (SUSAR) Reports
Clinical Risk Management Plans (RMPs)
Safety Assessment Reports
Responsibilities Include:
Data analysis and interpretation
Safety trend identification
Benefit-risk evaluation
Regulatory submission support
Response to Health Authority requests
Clinical Development Support
Provide safety expertise and medical input to:
Product Development Plans (PDPs)
Clinical Trial Protocols
Trial Outlines
Investigator’s Brochures (IBs)
Clinical Trial Reports (CTRs)
Integrated Safety Summaries
Scientific Abstracts
Publications and Manuscripts
Support clinical development teams by ensuring patient safety considerations are integrated into study design and execution.
Regulatory & Health Authority Interactions
Respond to safety-related inquiries from:
Regulatory Authorities
Ethics Committees
Internal Stakeholders
Global Affiliates
Support regulatory submissions involving safety data.
Prepare safety assessments and regulatory responses.
Ensure compliance with global pharmacovigilance regulations and reporting requirements.
Data Monitoring & Risk Management
Support Data Monitoring Committees (DMCs) and Independent Safety Committees.
Coordinate preparation and delivery of safety documentation.
Ensure timely completion of DMC deliverables.
Contribute to risk management planning and mitigation strategies.
Stakeholder Collaboration
Collaborate closely with:
Global Patient Safety Teams
Clinical Development
Medical Affairs
Regulatory Affairs
Biostatistics
Epidemiology
Clinical Operations
Quality Assurance
External Regulatory Agencies
Promote proactive safety communication and cross-functional decision-making.
Required Qualifications
Education
Preferred
MD (Doctor of Medicine)
OR
Master's Degree in Medicine after MBBS
Additional Relevant Qualifications
MBBS
PharmD
M.Pharm
Clinical Pharmacology
Pharmacovigilance
Life Sciences
may be considered depending on relevant experience and expertise.
Experience Requirements
Mandatory Experience
Experience in one or more of the following areas:
Signal Management
Aggregate Safety Reporting
Individual Case Safety Report (ICSR) Management
Pharmacovigilance Operations
Drug Safety Surveillance
Clinical Safety
Preferred Experience
Pharmaceutical Industry
Biotechnology Industry
CRO Environment
Global Pharmacovigilance Operations
Clinical Development Safety Support
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