Cencora – Manager Drug Safety Physician | Noida, India | Pharmacovigilance Leadership
Company: Cencora (Affiliated: PharmaLex India Private Limited)
Location: Noida, India
Job Type: Full-Time
Work Mode: On-site / Hybrid (project-dependent)
Experience: 5–7+ Years (Pharmacovigilance / Drug Safety)
Qualification: MBBS / MD (Mandatory)
Compensation: Not disclosed in the job description
Senior drug safety physician jobs in India are among the most critical and high-growth roles in the pharmaceutical industry, especially in aggregate reporting, risk management, and regulatory pharmacovigilance leadership.
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Job Summary
Cencora is hiring a Manager – Drug Safety Physician to lead pharmacovigilance operations, aggregate safety reporting, and regulatory risk management activities. This role focuses on PSUR, RMP, DSUR, and benefit-risk evaluation, ensuring compliance with global regulatory standards.
You will oversee safety writing, medical review, and pharmacovigilance strategy, while mentoring teams and interacting with global stakeholders and health authorities.
This is a high-impact leadership role ideal for professionals aiming to grow in:
Drug Safety Physician roles
Pharmacovigilance Leadership
Risk Management & Benefit-Risk Evaluation
Regulatory Affairs & Safety Writing
Key Responsibilities
Aggregate Safety Reporting & Medical Review
Lead development and review of:
PSUR / PBRER
Risk Management Plans (RMPs)
Development Safety Update Reports (DSURs)
Addendum to Clinical Overview (ACO)
Ensure scientific accuracy, regulatory compliance, and high-quality documentation
Risk Management & Benefit-Risk Strategy
Identify safety concerns and develop risk minimization strategies
Perform integrated benefit-risk evaluation
Align safety data across:
Clinical trials
Safety databases
Literature and epidemiology data
Regulatory Compliance & Health Authority Interaction
Respond to Health Authority (HA) queries and assessment reports
Track and implement HA feedback across safety documents
Ensure alignment with global regulatory frameworks (ICH-GVP, GxP)
Safety Writing & Documentation Oversight
Oversee end-to-end safety writing operations
Coordinate cross-functional inputs for RMP/PSUR/ACO annexes
Maintain consistency across safety documentation and regulatory submissions
Team Leadership & Mentorship
Mentor pharmacovigilance team members and ensure high performance
Conduct training sessions and develop training materials
Lead project activities, timelines, and deliverables
Stakeholder & Project Management
Act as key contact for clients and internal teams
Organize project kick-offs and manage deliverables
Ensure quality, timelines, and compliance across projects
Required Skills & Qualifications
MBBS / MD (mandatory for Drug Safety Physician role)
5–7+ years of experience in pharmacovigilance and drug safety
Strong expertise in:
Aggregate reporting (PSUR, DSUR, RMP, ACO)
Signal detection and safety evaluation
Medical review of ICSRs
Knowledge of:
ICH-GVP guidelines
Global regulatory requirements
Safety databases and reporting systems
Strong clinical judgment and analytical skills
Excellent communication and stakeholder management abilities
Preferred Skills (High-Impact SEO Keywords):
Benefit-Risk Assessment
Regulatory Safety Writing
Pharmacovigilance Consulting
Signal Management & Risk Evaluation
SOP Development & Compliance
Clinical Safety & Epidemiology
Perks & Benefits
Leadership role in global pharmacovigilance consulting projects
Exposure to international regulatory authorities and safety systems
Opportunity to manage high-impact drug safety strategies
Career growth into senior leadership roles in PV and regulatory affairs
Collaborative and global work environment
About the Company
Cencora is a global healthcare solutions provider delivering expertise in pharmacovigilance, regulatory affairs, and clinical development. Through PharmaLex, the company supports pharmaceutical organizations in ensuring drug safety, compliance, and successful product lifecycle management.
Why This Role is High-Value in Pharma Careers
The Manager – Drug Safety Physician role is one of the most powerful positions in pharmacovigilance. It directly impacts:
Patient safety and drug risk management
Regulatory approvals and compliance
Global safety strategies
This role provides exposure to:
Advanced safety reporting systems
Global regulatory authorities (EMA, FDA, etc.)
High-level benefit-risk decision-making
Career progression includes:
Senior Drug Safety Physician
Pharmacovigilance Director
Global Safety Lead
Head of Drug Safety
Application Process
Apply via the official Cencora careers portal
Highlight experience in:
PSUR / RMP / DSUR
Signal detection & safety evaluation
Regulatory writing & compliance
Use strong keywords:
Drug Safety Physician
Pharmacovigilance
Risk Management
ICH-GVP
Call to Action
If you’re ready to lead high-impact drug safety strategies and global pharmacovigilance operations, this is your opportunity.
Apply now and take your career to the next level in drug safety leadership with Cencora 🚀
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