Safety Physician | Clinical Development & Pharmacovigilance | Mumbai
Company: Abbott
Location: Mumbai, India (Mumbai Development Center – EPD)
Job Type: Full-Time
Work Mode: On-site
Experience: 5–7+ Years (Minimum 3 years in Clinical Development)
Job Overview
Abbott is seeking a Safety Physician to lead clinical safety oversight, pharmacovigilance activities, and medical strategy across global clinical programs. This role is central to ensuring patient safety, regulatory compliance, and scientific integrity throughout the drug development lifecycle.
As a Safety Physician, you will act as the clinical trial physician, providing expert medical guidance, overseeing adverse event monitoring, safety data analysis, and risk management, while contributing to clinical development strategies and regulatory submissions.
This is a high-impact role for professionals aiming to operate at the intersection of clinical research, drug safety, and global regulatory strategy.
Key Responsibilities
Clinical Safety & Trial Oversight
Act as clinical trial physician ensuring safety of all study participants
Provide medical oversight and scientific expertise across clinical programs
Serve as primary contact for medical-scientific queries during trials
Pharmacovigilance & Drug Safety
Review and assess Serious Adverse Events (SAEs) and safety data
Perform SAE reconciliation, safety listings review, and signal detection
Collaborate with global pharmacovigilance (PV) teams
Review case narratives and medical coding
Regulatory & Clinical Documentation
Prepare and review clinical safety sections of:
Clinical study protocols
Investigator’s Brochures (IB)
Clinical Study Reports (CSR)
CTD Modules (2.5, 2.7)
Support responses to Ethics Committees (EC), Ministry of Health (MoH), and regulatory authorities
Risk Management & Safety Strategy
Contribute to Risk Management Plans (RMPs), PSURs, DSURs
Implement protocol modifications based on safety/efficacy findings
Support safety-related updates in informed consent documents
Clinical Development Strategy
Support Global Clinical Directors (GCDs) in strategy development
Contribute to Target Product Profiles (TPP) and pipeline evaluation
Analyze clinical data for insights, label expansion, and publications
Data Analysis & Medical Writing
Participate in statistical analysis plans and data interpretation meetings
Support clinical study reports and medical writing activities
Conduct data mining and integrated safety/efficacy analysis
Cross-Functional Collaboration
Work with Regulatory Affairs, Medical Affairs, Clinical Operations, and Commercial teams
Interact with Key Opinion Leaders (KOLs) for clinical insights
Support product lifecycle management and innovation
Required Skills & Qualifications
Educational Qualification
MBBS or MD (Mandatory)
Experience
5–7+ years in pharmaceutical industry
Minimum 3 years in clinical development / drug safety / pharmacovigilance
Technical Skills
Strong expertise in clinical trial methodology and safety monitoring
In-depth knowledge of ICH-GCP, FDA/EMA regulatory guidelines
Experience in pharmacovigilance, SAE reporting, and risk management
Familiarity with CTD documentation, PSUR, DSUR, RMP
Exposure to clinical data analysis, medical writing, and regulatory submissions
Core Competencies
Strong decision-making and risk assessment skills
Excellent communication and stakeholder management
Ability to work independently in global, cross-functional teams
Strategic thinking and problem-solving mindset
Leadership and influence without authority
Perks & Benefits
Opportunity to work with a top global pharmaceutical leader
Exposure to global clinical trials and safety strategies
Career growth in Clinical Development, Pharmacovigilance, and Medical Affairs
Work on innovative therapies and emerging markets
High-impact role influencing patient safety and regulatory decisions
Compensation
Salary Range: Not disclosed (highly competitive for Safety Physician roles in pharma industry)
About the Company
Abbott is a global healthcare leader focused on pharmaceuticals, diagnostics, medical devices, and nutrition. With a strong emphasis on clinical innovation, patient safety, and regulatory excellence, Abbott continues to advance global healthcare outcomes through science-driven solutions.
Why This Role is Elite-Level
This role is ideal for professionals aiming to lead in:
Clinical Development & Drug Safety
Pharmacovigilance & Risk Management
Regulatory Affairs & Global Submissions
Medical Strategy & Clinical Leadership
Global Drug Development Lifecycle
Application Process
Apply through Abbott’s official careers portal.
Call to Action
If you want to operate at the highest level of clinical safety and drug development, influencing how medicines are evaluated and approved globally — this is your arena.
Step into elite-level pharma strategy, safety leadership, and global clinical impact.
Apply now and take control of your future in clinical development. 🚀
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