Drug Safety Physician

Why This Role Matters
• Ensures patient safety through accurate pharmacovigilance and medical review
• Strengthens regulatory compliance in global drug safety operations
• Supports benefit-risk evaluation of pharmaceutical products
• Contributes to signal detection and proactive risk management
• Enhances quality and audit readiness in safety reporting processes

Job Description
• Position: Drug Safety Physician / Senior Drug Safety Physician
• Organisation: OrciMed Life Sciences
• Location: India
• Employment Type: Full Time
• Salary Range: ₹12,00,000 – ₹28,00,000 per annum
• Experience Required: 1–5 years in Medical Review of ICSRs

Key Features of the Role
• Competitive salary package based on experience
• Exposure to global pharmacovigilance systems
• Opportunity to work with international pharma and biotech clients
• Involvement in signal detection and aggregate reporting
• Leadership scope for Senior Drug Safety Physician role
• Participation in audit readiness and quality initiatives

Responsibilities
• Perform medical review of Individual Case Safety Reports (ICSRs)
• Assess seriousness, causality and expectedness of adverse events
• Ensure regulatory compliance and medical accuracy of safety cases
• Provide clinical input into signal detection activities
• Review narratives for medical consistency and completeness
• Support aggregate safety report review when required
• Collaborate with pharmacovigilance and case processing teams
• Respond to medical queries from regulatory authorities
• Participate in quality review and audit preparation
• Guide and mentor junior safety associates
• Contribute to risk management and benefit-risk assessments
• Support SOP development and process improvement initiatives
• Ensure adherence to GVP and ICH guidelines
• Maintain accurate documentation of medical review activities

Required Qualifications
• MBBS degree
• Registered Medical Practitioner in India
• 1–5 years’ experience in ICSR medical review
• Strong understanding of global pharmacovigilance regulations

Educational Requirements
• Bachelor of Medicine, Bachelor of Surgery (MBBS)
• Valid medical registration in India

Experience and Skills
• Expertise in Medical Review and ICSR assessment
• Strong knowledge of causality and seriousness assessment
• Experience in pharmacovigilance and drug safety
• Familiarity with GVP and ICH Guidelines
• Understanding of signal detection and risk management
• Ability to perform clinical evaluation and regulatory documentation
• Strong analytical and communication skills

Age Eligibility
• Open to qualified MBBS professionals meeting registration and experience requirements in India

Salary Insights
• ₹12 LPA – ₹28 LPA depending on role level and experience
• Higher compensation range aligned with Senior Drug Safety Physician designation
• Competitive package within Indian pharmacovigilance industry standards

Company Overview
• OrciMed Life Sciences is a global clinical research organisation
• Provides pharmacovigilance, clinical data management and regulatory services
• Supports international pharmaceutical and biotechnology companies
• Focused on compliance, safety excellence and regulatory quality standards

FAQs

Q1. What qualification is mandatory for this role?
An MBBS degree with valid registration as a Medical Practitioner in India is mandatory.

Q2. What experience is required?
Candidates should have 1–5 years of experience in medical review of ICSRs.

Q3. What is the salary range?
The salary ranges from ₹12,00,000 to ₹28,00,000 per annum depending on experience and designation.

Q4. Is prior pharmacovigilance experience required?
Yes, experience in pharmacovigilance, ICSR review and regulatory compliance is essential.

Q5. Are international guidelines knowledge required?
Yes, familiarity with GVP and ICH guidelines is required for this position.

Application Tips
• Highlight hands-on experience in ICSR medical review
• Mention exposure to global pharmacovigilance regulations
• Demonstrate expertise in causality and seriousness assessment
• Emphasise audit readiness and quality review involvement
• Clearly state medical registration details in your CV