Safety Physician
Location: Bangalore, Karnataka, India
Job Type: Regular | Full-Time
Division: Precision for Medicine
Business Unit: Clinical Solutions
Position Summary:
Precision for Medicine is seeking a highly skilled Drug Safety Physician responsible for the overall pharmacovigilance function, including the medical review and oversight of all types of safety events. The role supports safety data analysis, serious adverse event (SAE) processing, risk-benefit evaluation, and ensures compliance with global regulatory safety reporting requirements (FDA, EMA, ICH, etc.). The position plays a critical role in the clinical development lifecycle and safety governance of investigational and marketed products.
Key Responsibilities:
Safety Oversight & Medical Review:
Lead drug safety and pharmacovigilance functions including risk communication and mitigation strategies.
Provide clinical insights for individual SAE assessments and aggregate safety reviews.
Participate in ongoing risk-benefit evaluations, signal detection, and medical review of safety data.
Cross-functional & Regulatory Support:
Collaborate with internal teams and external CROs for safety monitoring and reporting.
Provide medical input into protocols, study reports, IBs, ICFs, and regulatory responses.
Serve as the safety lead for DSMBs and cohort reviews during Phase 1 trials.
Ensure safety compliance across global territories and effective use of safety databases.
Systems, SOPs & Audit Readiness:
Oversee safety system(s), coding reviews, and database reconciliations.
Maintain audit and inspection readiness at all times.
Participate in the development of Risk Management Plans, Pharmacovigilance System Master Files, and acquisition of QPPV support.
Establish robust vendor governance and internal SOPs.
Education & Experience Requirements:
MBBS / MD with a minimum of 7 years in Drug Safety and Pharmacovigilance.
At least 3 years in early clinical development, preferably in oncology.
Hands-on experience with case processing, preferably using ARGUS.
Proven authorship or contributions to regulatory safety reports and successful interactions with agencies.
Experience with clinical trials, particularly in hematology/oncology therapeutic areas.
Skills & Competencies:
Strong grasp of FDA, EMA, ICH, and global regulatory frameworks.
Expertise in medical terminology, clinical assessments, and benefit-risk profiling.
Proficient in Microsoft Office and safety databases.
Highly organized with a sense of urgency, initiative, and accountability.
Excellent verbal and written communication skills.
Effective team player with leadership capabilities and supervisory experience.
Less than 20% travel required.
Core Competencies:
Consistent delivery on safety commitments.
Ability to lead cross-functional discussions on safety issues.
Regulatory compliance monitoring.
Participation in process improvement initiatives within Drug Safety.
Estimated Salary: ₹35–50 LPA
Slug: safety-physician-bangalore-precision-for-medicine
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