Instagram
youtube
Facebook

Senior Drug Safety Physician

0 years
Not Disclosed
10 Nov. 18, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Senior Drug Safety Physician

Location: Karnataka, India
Date Posted: 17 November 2025
Experience Required: Fresher eligible (0 years). Candidates with clinical internships, medical training, or academic exposure to pharmacology, drug safety, or patient case evaluation will be considered.


About the Company

We are a global, technology-driven healthcare solutions provider dedicated to helping healthcare organizations become future-ready. Our environment is built on innovation, scientific excellence, and advanced digital healthcare delivery. Fresh medical graduates joining our team receive structured mentorship, exposure to global pharmacovigilance operations, and opportunities to build a long-term career in drug safety and medical review.


Role Overview: Senior Drug Safety Physician

This role involves supporting global pharmacovigilance functions through the medical review of individual case safety reports (ICSRs), assessment of adverse event reports, and ensuring medical completeness and regulatory compliance. Freshers with strong clinical reasoning and scientific aptitude are encouraged to apply.


Key Responsibilities

Medical Review and Case Evaluation

• Conduct medical review of ICSRs for accuracy, completeness, relevance, and alignment with supporting documents
• Evaluate adverse events (AEs) and serious adverse events (SAEs) for seriousness, expectedness, and listedness
• Provide medical causality assessment using global introspection and clinical judgment
• Review case narrative, coding, labeling, medical history, and overall case quality
• Provide medical sign-off for cases as applicable

Safety Surveillance Activities

• Review non-serious AE line listings to ensure appropriate coding and evaluation
• Perform unblinding activities when required
• Prepare follow-up questions to ensure complete clinical information
• Conduct literature surveillance where applicable
• Review Analyses of Similar Events (AOSE) for expedited case submissions
• Support aggregate safety reviews across clinical, post-marketing, and literature data sources

Quality and Compliance

• Track inconsistencies in case processing and provide constructive feedback to improve data quality
• Ensure adherence to global pharmacovigilance regulations, company SOPs, and compliance standards
• Contribute to risk management planning and safety surveillance strategies
• Review and update SOPs and support global quality initiatives
• Support RCA and CAPA processes and communicate findings to relevant stakeholders

Cross-Functional Communication

• Present quality assurance data to internal stakeholders
• Attend internal and client trainings, governance meetings, and compliance sessions
• Collaborate with global teams to uphold high standards in safety case management


Skills and Competencies

• Strong clinical reasoning, scientific accuracy, and analytical thinking
• Excellent attention to detail and comprehension skills
• Solid understanding of disease pathology, physiology, pharmacology, and therapeutic principles
• Ability to interpret clinical data and understand project objectives
• Effective communication and interpersonal skills
• Ability to uphold quality standards and meet timelines
• Familiarity with pharmacovigilance concepts and drug safety databases (preferred but not mandatory)
• Ability to mentor and guide team members when required


Ideal for Freshers Seeking a Drug Safety Career

• Builds core expertise in pharmacovigilance operations
• Offers exposure to global safety regulations and case evaluation frameworks
• Provides structured clinical, medical, and PV system training
• Supports long-term growth as a Drug Safety Physician or Medical Reviewer