Clinical Safety Physician
Location: Mumbai, India
Experience Required: 10–15 years
Apply By: 21-Jul-2026
Job Function: Business Process Services
Role Level: Lead
About the Role
The Clinical Safety Physician is responsible for overseeing clinical safety activities across drug development and post-marketing phases. The role focuses on pharmacovigilance, safety signal management, and regulatory safety reporting to ensure patient safety and compliance with global regulatory standards.
Key Responsibilities
1. Safety Data Review & Interpretation
Review and interpret clinical safety data.
Evaluate Individual Case Safety Reports (ICSRs).
Support safety decision-making based on clinical evidence.
2. Literature Review & Signal Detection
Perform literature reviews related to:
ICSRs
Safety signals
Aggregate reports
Conduct signal detection, validation, and evaluation.
3. Regulatory Safety Reporting
Author and review key safety documents including:
DSUR (Development Safety Update Reports)
PBRER (Periodic Benefit-Risk Evaluation Reports)
Drug Safety Reports (DSR)
Ensure compliance with global regulatory requirements.
4. Signal Management
Identify, validate, and manage safety signals.
Support benefit-risk assessment of investigational and marketed products.
Collaborate with pharmacovigilance and regulatory teams.
5. Compliance & Cross-Functional Collaboration
Ensure adherence to global pharmacovigilance regulations.
Work with cross-functional teams for safety oversight.
Support regulatory inspections and audits.
Educational Qualifications
Mandatory: MBBS and/or MD
Preferred backgrounds (depending on employer requirements):
B.Pharm
M.Pharm
B.Sc / M.Sc (Life Sciences or related fields)
Key Skills Required
Clinical & Pharmacovigilance Expertise
Strong understanding of pharmacovigilance systems.
Experience in:
Signal detection and validation
Safety data interpretation
Aggregate safety reporting
Regulatory Knowledge
Knowledge of global PV regulations.
Experience with:
DSUR
PBRER
ICSR processing
Analytical Skills
Ability to interpret complex clinical safety data.
Strong scientific and medical reasoning skills.
Communication Skills
Ability to write regulatory-grade safety reports.
Strong written and verbal communication in medical/scientific context.
Desired Candidate Profile
Strong experience in pharmacovigilance (LS – PV domain).
Experience handling global safety databases and regulatory submissions.
Ability to work in high-responsibility, regulated environments.
Summary
The Clinical Safety Physician is a highly senior medical role responsible for:
Drug safety oversight
Signal management
Regulatory reporting
Benefit-risk evaluation
Global pharmacovigilance leadership
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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