Drug Safety Physician (Pharmacovigilance)

Why This Role Matters
Drug Safety Physicians play a critical role in safeguarding patient health by ensuring accurate medical review of safety data, compliance with global pharmacovigilance regulations, and timely risk assessment of medicinal products. Their expertise directly impacts regulatory decisions, labeling updates, and benefit-risk evaluation across marketed and investigational products.

Job Description
We are hiring Drug Safety Physicians with mandatory pharmacovigilance experience to support global drug safety operations. The role involves medical review of Individual Case Safety Reports (ICSRs), evaluation of safety signals, contribution to aggregate reports, and collaboration with cross-functional stakeholders to ensure regulatory compliance and patient safety.

Key Features of the Role:
• Position: Drug Safety Physician
• Qualification: MBBS or MD
• Experience: 2–5 years in Pharmacovigilance (mandatory)
• Exposure to global safety regulations
• Work on both marketed and investigational products
• Involvement in signal management and aggregate reporting

Responsibilities
• Provide medical expertise and guidance to PV Scientists for ICSR processing
• Perform detailed medical review of ICSRs (human and veterinary products)
• Evaluate published literature for safety data
• Draft Analysis of Similar Events (AOSE) for SUSARs
• Contribute to and/or medically review aggregate safety reports including PSURs, PADERs, DSURs
• Support preparation and review of Risk Management Plans (RMPs)
• Participate in signal detection, validation, prioritization, analysis, and assessment
• Maintain knowledge of product safety profiles, labeling documents, and SOPs
• Ensure compliance with global pharmacovigilance guidelines
• Collaborate with internal and external stakeholders to resolve safety queries
• Stay updated on international drug safety regulations

Required Qualifications
• MBBS or MD
• 2–5 years of pharmacovigilance experience (mandatory)
• Strong knowledge of global PV regulations
• Experience in regulated environments

Educational Requirements:
• MBBS (mandatory)
• MD preferred

Experience and Skills:
• Strong medical evaluation and clinical judgment skills
• Expertise in ICSR medical review and aggregate reporting
• Familiarity with SUSARs and AOSE preparation
• Knowledge of GVP, FDA, and international safety regulations
• Excellent communication and cross-functional collaboration skills
• High attention to detail and analytical capability

Age Eligibility:
As per company norms

Salary Insights
Compensation details not disclosed. Salary will be aligned with industry standards based on experience and expertise.

Company Overview
The hiring organization operates within the pharmacovigilance and drug safety domain, supporting pharmaceutical and biotechnology companies in global regulatory compliance, safety monitoring, and risk management activities.

FAQs

Is pharmacovigilance experience mandatory?
Yes, 2–5 years of PV experience is mandatory.

Is an MD required?
MBBS is mandatory; MD is preferred.

Does the role involve aggregate report writing?
Yes, including PSURs, PADERs, DSURs, and RMPs.

Will I work on signal management?
Yes, signal detection and assessment are key responsibilities.

Are both marketed and investigational products included?
Yes, the role covers both categories.

Application Tips
• Highlight ICSR medical review experience clearly
• Mention aggregate report exposure (PSUR, DSUR, PADER)
• Emphasize signal management experience
• Include regulatory knowledge (GVP, FDA guidelines)
• Showcase cross-functional collaboration and medical decision-making skills